NDC Code(s) : 63629-1502-2, 63629-1502-6, 63629-1502-7, 63629-1502-5, 63629-1502-4, 63629-1502-3, 63629-1502-8, 63629-1502-1
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Tetracycline HydrochlorideTetracycline Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-1502(NDC:0591-2235)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRACYCLINE HYDROCHLORIDE(UNII: P6R62377KV)
(TETRACYCLINE - UNII:F8VB5M810T) 		TETRACYCLINE HYDROCHLORIDE500 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
BENZYL ALCOHOL(UNII: LKG8494WBH)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
EDETATE CALCIUM DISODIUM(UNII: 25IH6R4SGF)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM PROPIONATE(UNII: DK6Y9P42IN)
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
ALCOHOL(UNII: 3K9958V90M)
ETHYLENE GLYCOL MONOETHYL ETHER(UNII: IDK7C2HS09)
SHELLAC(UNII: 46N107B71O)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
Product Characteristics
Color BLACK (Black Opaque Cap), YELLOW (Yellow Opaque Body) Score no score
Shape CAPSULE (CAPSULE) Size 22 mm
Flavor Imprint Code WPI;2235
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63629-1502-240 in 1 BOTTLE Type 0: Not a Combination Product19/12/2010
2NDC:63629-1502-620 in 1 BOTTLE Type 0: Not a Combination Product19/12/2010
3NDC:63629-1502-790 in 1 BOTTLE Type 0: Not a Combination Product19/12/2010
4NDC:63629-1502-528 in 1 BOTTLE Type 0: Not a Combination Product19/12/2010
5NDC:63629-1502-456 in 1 BOTTLE Type 0: Not a Combination Product19/12/2010
6NDC:63629-1502-330 in 1 BOTTLE Type 0: Not a Combination Product19/12/2010
7NDC:63629-1502-845 in 1 BOTTLE Type 0: Not a Combination Product19/12/2010
8NDC:63629-1502-160 in 1 BOTTLE Type 0: Not a Combination Product19/12/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA061837 12/19/2010

PRINCIPAL DISPLAY PANEL

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