NDC 0641-6082

PHENERGAN

Promethazine Hydrochloride

PHENERGAN is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Promethazine Hydrochloride.

Product ID0641-6082_e134cda8-8ad2-4863-906b-83e57303806c
NDC0641-6082
Product TypeHuman Prescription Drug
Proprietary NamePHENERGAN
Generic NamePromethazine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date1973-09-19
Marketing CategoryANDA / ANDA
Application NumberANDA083312
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/mL
Pharm ClassesPhenothiazine [EPC], Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0641-6082-25

25 AMPULE in 1 CARTON (0641-6082-25) > 1 mL in 1 AMPULE (0641-6082-01)
Marketing Start Date1973-09-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0641-6082-25 [00641608225]

PHENERGAN INJECTION
Marketing CategoryANDA
Application NumberANDA083312
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1973-09-19

NDC 0641-6082-01 [00641608201]

PHENERGAN INJECTION
Marketing CategoryANDA
Application NumberANDA083312
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1973-09-19

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/mL

OpenFDA Data

SPL SET ID:6f7e47cc-f823-4336-8107-f980e3049617
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992876
  • 992460
  • 992858
  • 992462

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0641-6082PHENERGANPromethazine Hydrochloride
    0641-6083PHENERGANPromethazine Hydrochloride
    0641-6084PHENERGANPromethazine Hydrochloride
    0641-6085PHENERGANPHENERGAN
    61919-396PHENERGANPHENERGAN
    70518-2656PHENERGANPHENERGAN
    0591-2985PHENADOZPromethazine Hydrochloride
    0591-2992PHENADOZPromethazine Hydrochloride
    0615-1539PromethazinePromethazine Hydrochloride
    0121-0927Promethazine HydrochloridePromethazine Hydrochloride
    0404-9940PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE
    0404-9941Promethazine HydrochloridePromethazine Hydrochloride
    0404-9942Promethazine HydrochloridePromethazine Hydrochloride
    0440-5195Promethazine HydrochloridePromethazine Hydrochloride
    0440-8195Promethazine HydrochloridePromethazine Hydrochloride
    0591-5307Promethazine HydrochloridePromethazine Hydrochloride
    0591-5319Promethazine HydrochloridePromethazine Hydrochloride
    0603-1584Promethazine HydrochloridePromethazine Hydrochloride
    0615-7668promethazine hydrochloridepromethazine hydrochloride
    0615-8154Promethazine HydrochloridePromethazine Hydrochloride
    0641-0928Promethazine HydrochloridePromethazine Hydrochloride
    0641-0929Promethazine HydrochloridePromethazine Hydrochloride
    0641-0948Promethazine HydrochloridePromethazine Hydrochloride
    0641-0949Promethazine HydrochloridePromethazine Hydrochloride
    0641-0955Promethazine HydrochloridePromethazine Hydrochloride
    0641-0956Promethazine HydrochloridePromethazine Hydrochloride
    0641-1495Promethazine HydrochloridePromethazine Hydrochloride
    0641-1496Promethazine HydrochloridePromethazine Hydrochloride

    Trademark Results [PHENERGAN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PHENERGAN
    PHENERGAN
    98588669 not registered Live/Pending
    Rising Pharma Holdings, Inc.
    2024-06-06
    PHENERGAN
    PHENERGAN
    97852996 not registered Live/Pending
    WOODWARD SPECIALTY LLC
    2023-03-23
    PHENERGAN
    PHENERGAN
    77909935 3818335 Live/Registered
    DELCOR ASSET CORPORATION
    2010-01-12
    PHENERGAN
    PHENERGAN
    71550837 0507057 Live/Registered
    SOCIETE DES USINES CHIMIQUES RHONE-POULENC
    1948-02-28
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.