NDC Code(s) : 0186-0412-01, 0186-0410-01, 0186-0418-01, 0186-0422-01, 0186-0420-01
Packager : AstraZeneca Pharmaceuticals LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

POLOCAINEMepivacaine Hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0412
Route of Administration INFILTRATION DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mepivacaine Hydrochloride(UNII: 4VFX2L7EM5)
(Mepivacaine - UNII:B6E06QE59J) 		Mepivacaine Hydrochloride10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium hydroxide(UNII: 55X04QC32I)
hydrochloric acid(UNII: QTT17582CB)
sodium chloride(UNII: 451W47IQ8X)6.6 mg in 1 mL
potassium chloride(UNII: 660YQ98I10)0.3 mg in 1 mL
calcium chloride(UNII: M4I0D6VV5M)0.33 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0186-0412-0130 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product01/07/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089406 07/01/1990 05/31/2012
POLOCAINEMepivacaine Hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0410
Route of Administration INFILTRATION DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mepivacaine Hydrochloride(UNII: 4VFX2L7EM5)
(Mepivacaine - UNII:B6E06QE59J) 		Mepivacaine Hydrochloride10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium hydroxide(UNII: 55X04QC32I)
hydrochloric acid(UNII: QTT17582CB)
sodium chloride(UNII: 451W47IQ8X)7 mg in 1 mL
METHYLPARABEN(UNII: A2I8C7HI9T)1 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0186-0410-0150 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product01/07/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089407 07/01/1990 12/31/2012
POLOCAINEMepivacaine Hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0418
Route of Administration INFILTRATION DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mepivacaine Hydrochloride(UNII: 4VFX2L7EM5)
(Mepivacaine - UNII:B6E06QE59J) 		Mepivacaine Hydrochloride15 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium hydroxide(UNII: 55X04QC32I)
hydrochloric acid(UNII: QTT17582CB)
sodium chloride(UNII: 451W47IQ8X)5.6 mg in 1 mL
potassium chloride(UNII: 660YQ98I10)0.3 mg in 1 mL
calcium chloride(UNII: M4I0D6VV5M)0.33 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0186-0418-0130 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product30/09/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089408 09/30/1990 08/31/2012
POLOCAINEMepivacaine Hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0422
Route of Administration INFILTRATION DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mepivacaine Hydrochloride(UNII: 4VFX2L7EM5)
(Mepivacaine - UNII:B6E06QE59J) 		Mepivacaine Hydrochloride20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium hydroxide(UNII: 55X04QC32I)
hydrochloric acid(UNII: QTT17582CB)
sodium chloride(UNII: 451W47IQ8X)5.6 mg in 1 mL
potassium chloride(UNII: 660YQ98I10)0.3 mg in 1 mL
calcium chloride(UNII: M4I0D6VV5M)0.33 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0186-0422-0120 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product30/09/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089409 09/30/1990 03/31/2013
POLOCAINEMepivacaine Hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0420
Route of Administration INFILTRATION DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mepivacaine Hydrochloride(UNII: 4VFX2L7EM5)
(Mepivacaine - UNII:B6E06QE59J) 		Mepivacaine Hydrochloride20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium hydroxide(UNII: 55X04QC32I)
hydrochloric acid(UNII: QTT17582CB)
sodium chloride(UNII: 451W47IQ8X)5 mg in 1 mL
METHYLPARABEN(UNII: A2I8C7HI9T)1 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0186-0420-0150 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product30/09/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089410 09/30/1990 09/30/2012

PRINCIPAL DISPLAY PANEL

Product Discontinued

PRINCIPAL DISPLAY PANEL

Product Discontinued

PRINCIPAL DISPLAY PANEL

Product Discontinued

PRINCIPAL DISPLAY PANEL

Product Discontinued

PRINCIPAL DISPLAY PANEL

Product Discontinued