NDC Code 64679-272-03 - Lamotrigine

NDC Code(s) : 64679-271-01, 64679-271-02, 64679-271-03, 64679-271-04, 64679-274-01, 64679-274-02, 64679-274-04, 64679-274-03, 64679-273-01, 64679-273-02, 64679-273-03, 64679-273-04, 64679-272-01, 64679-272-02, 64679-272-03, 64679-272-04, 64679-275-01, 64679-275-02, 64679-275-03, 64679-275-04
Packager : Wockhardt USA LLC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LamotrigineLamotrigine TABLET, EXTENDED RELEASE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64679-271
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LAMOTRIGINE(UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)	LAMOTRIGINE	25 mg

Ingredient Name	Strength
Inactive Ingredients
DIETHYL PHTHALATE(UNII: UF064M00AF)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)

Product Characteristics
Color	yellow (yellow, coated)	Score	no score
Shape	ROUND (circular shaped tablets)	Size	10 mm
Flavor		Imprint Code	W;271
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64679-271-01	30 in 1 BOTTLE Type 0: Not a Combination Product	29/11/2012
2	NDC:64679-271-02	500 in 1 BOTTLE Type 0: Not a Combination Product	29/11/2012
3	NDC:64679-271-04	10 in 1 CARTON	29/11/2012
3	NDC:64679-271-03	10 in 1 BLISTER PACK Type 0: Not a Combination Product	29/11/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202498	11/29/2012

LamotrigineLamotrigine TABLET, EXTENDED RELEASE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64679-274
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LAMOTRIGINE(UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)	LAMOTRIGINE	50 mg

Ingredient Name	Strength
Inactive Ingredients
DIETHYL PHTHALATE(UNII: UF064M00AF)
FERRIC OXIDE RED(UNII: 1K09F3G675)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)

Product Characteristics
Color	pink (pink, coated)	Score	no score
Shape	ROUND (circular shaped tablets)	Size	10 mm
Flavor		Imprint Code	W;274
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64679-274-01	30 in 1 BOTTLE Type 0: Not a Combination Product	29/11/2012
2	NDC:64679-274-02	500 in 1 BOTTLE Type 0: Not a Combination Product	29/11/2012
3	NDC:64679-274-03	10 in 1 CARTON	29/11/2012
3	NDC:64679-274-04	10 in 1 BLISTER PACK Type 0: Not a Combination Product	29/11/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202498	11/29/2012

LamotrigineLamotrigine TABLET, EXTENDED RELEASE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64679-273
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LAMOTRIGINE(UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)	LAMOTRIGINE	100 mg

Ingredient Name	Strength
Inactive Ingredients
DIETHYL PHTHALATE(UNII: UF064M00AF)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)

Product Characteristics
Color	brown (light brown, coated)	Score	no score
Shape	ROUND (circular shaped tablets)	Size	10 mm
Flavor		Imprint Code	W;273
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64679-273-01	30 in 1 BOTTLE Type 0: Not a Combination Product	29/11/2012
2	NDC:64679-273-02	500 in 1 BOTTLE Type 0: Not a Combination Product	29/11/2012
3	NDC:64679-273-04	10 in 1 CARTON	29/11/2012
3	NDC:64679-273-03	10 in 1 BLISTER PACK Type 0: Not a Combination Product	29/11/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202498	11/29/2012

LamotrigineLamotrigine TABLET, EXTENDED RELEASE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64679-272
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LAMOTRIGINE(UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)	LAMOTRIGINE	200 mg

Ingredient Name	Strength
Inactive Ingredients
DIETHYL PHTHALATE(UNII: UF064M00AF)
FERRIC OXIDE RED(UNII: 1K09F3G675)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)

Product Characteristics
Color	pink (Pink, coated)	Score	no score
Shape	ROUND (circular shaped tablets)	Size	10 mm
Flavor		Imprint Code	W;272
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64679-272-01	30 in 1 BOTTLE Type 0: Not a Combination Product	29/11/2012
2	NDC:64679-272-02	500 in 1 BOTTLE Type 0: Not a Combination Product	29/11/2012
3	NDC:64679-272-04	10 in 1 CARTON	29/11/2012
3	NDC:64679-272-03	10 in 1 BLISTER PACK Type 0: Not a Combination Product	29/11/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202498	11/29/2012

LamotrigineLamotrigine TABLET, EXTENDED RELEASE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64679-275
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LAMOTRIGINE(UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)	LAMOTRIGINE	300 mg

Ingredient Name	Strength
Inactive Ingredients
DIETHYL PHTHALATE(UNII: UF064M00AF)
FERRIC OXIDE RED(UNII: 1K09F3G675)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)

Product Characteristics
Color	pink (Pink, coated)	Score	no score
Shape	ROUND (circular shaped tablets)	Size	11 mm
Flavor		Imprint Code	W;275
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64679-275-01	30 in 1 BOTTLE Type 0: Not a Combination Product	29/11/2012
2	NDC:64679-275-02	500 in 1 BOTTLE Type 0: Not a Combination Product	29/11/2012
3	NDC:64679-275-04	10 in 1 CARTON	29/11/2012
3	NDC:64679-275-03	10 in 1 BLISTER PACK Type 0: Not a Combination Product	29/11/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202498	11/29/2012

LABELER - Wockhardt USA LLC.(170508365)

REGISTRANT - Atlantide Pharmaceuticals AG(480475252)

Establishment
Name	Address	ID/FEI	Business Operations
Wockhardt Limited		676257570	analysis(64679-271, 64679-272, 64679-273, 64679-274, 64679-275), manufacture(64679-271, 64679-272, 64679-273, 64679-274, 64679-275), label(64679-271, 64679-272, 64679-273, 64679-274, 64679-275), pack(64679-271, 64679-272, 64679-273, 64679-274, 64679-275)

NDC 64679-272-03
API & Excipient Details

Lamotrigine marketed by Wockhardt USA LLC. under NDC Code 64679-272-03

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 64679-272-03 API & Excipient Details

Lamotrigine marketed by Wockhardt USA LLC. under NDC Code 64679-272-03

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 64679-272-03
API & Excipient Details