NDC 54348-117

Promethazine

Promethazine

Promethazine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pharmpak, Inc.. The primary component is Promethazine Hydrochloride.

Product ID54348-117_8f7527b3-28b7-1871-e053-2995a90abfa6
NDC54348-117
Product TypeHuman Prescription Drug
Proprietary NamePromethazine
Generic NamePromethazine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-11
Marketing CategoryANDA / ANDA
Application NumberANDA040712
Labeler NamePharmPak, Inc.
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54348-117-00

1 BOTTLE in 1 BOX (54348-117-00) > 1 TABLET in 1 BOTTLE
Marketing Start Date2019-07-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54348-117-10 [54348011710]

Promethazine TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

NDC 54348-117-03 [54348011703]

Promethazine TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

NDC 54348-117-09 [54348011709]

Promethazine TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

NDC 54348-117-02 [54348011702]

Promethazine TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

NDC 54348-117-00 [54348011700]

Promethazine TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

NDC 54348-117-04 [54348011704]

Promethazine TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

NDC 54348-117-06 [54348011706]

Promethazine TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

NDC 54348-117-08 [54348011708]

Promethazine TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

NDC 54348-117-05 [54348011705]

Promethazine TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

NDC 54348-117-12 [54348011712]

Promethazine TABLET
Marketing CategoryANDA
Application NumberANDA040712
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:4f681538-7ac4-484c-9e6d-b571d73b9e0b
Manufacturer
UNII

Pharmacological Class

  • Phenothiazine [EPC]
  • Phenothiazines [CS]
  • Phenothiazine [EPC]
  • Phenothiazines [CS]

NDC Crossover Matching brand name "Promethazine" or generic name "Promethazine"

NDCBrand NameGeneric Name
0615-1539PromethazinePromethazine Hydrochloride
43063-708PromethazinePromethazine Hydrochloride
54348-117PromethazinePROMETHAZINE
65162-678Promethazine HydrochloridePromethazine

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