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PROMETHAZINE VC WITH CODEINE - 0472-1629-04 - (PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE)

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Drug Information of PROMETHAZINE VC WITH CODEINE

Product NDC: 0472-1629
Proprietary Name: PROMETHAZINE VC WITH CODEINE
Non Proprietary Name: PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Active Ingredient(s): 10; 5; 6.25    mg/5mL; mg/5mL; mg/5mL & nbsp;   PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Administration Route(s): ORAL
Dosage Form(s): SYRUP
Coding System: National Drug Codes(NDC)

Labeler Information of PROMETHAZINE VC WITH CODEINE

Product NDC: 0472-1629
Labeler Name: Actavis Mid Atlantic LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA088764
Marketing Category: ANDA
Start Marketing Date: 20111219

Package Information of PROMETHAZINE VC WITH CODEINE

Package NDC: 0472-1629-04
Package Description: 118 mL in 1 BOTTLE (0472-1629-04)

NDC Information of PROMETHAZINE VC WITH CODEINE

NDC Code 0472-1629-04
Proprietary Name PROMETHAZINE VC WITH CODEINE
Package Description 118 mL in 1 BOTTLE (0472-1629-04)
Product NDC 0472-1629
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Dosage Form Name SYRUP
Route Name ORAL
Start Marketing Date 20111219
Marketing Category Name ANDA
Labeler Name Actavis Mid Atlantic LLC
Substance Name CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Strength Number 10; 5; 6.25
Strength Unit mg/5mL; mg/5mL; mg/5mL
Pharmaceutical Classes Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC]

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