NDC 51662-1248

PROMETHAZINE HCI

Promethazine Hci

PROMETHAZINE HCI is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Hf Acquisition Co. Llc, Dba Healthfirst. The primary component is Promethazine Hydrochloride.

Product ID51662-1248_744bcc7b-a1b4-1b72-e053-2a91aa0a7c3a
NDC51662-1248
Product TypeHuman Prescription Drug
Proprietary NamePROMETHAZINE HCI
Generic NamePromethazine Hci
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-08-26
Marketing CategoryANDA / ANDA
Application NumberANDA083312
Labeler NameHF Acquisition Co. LLC, DBA HealthFirst
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength50 mg/mL
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51662-1248-1

1 mL in 1 AMPULE (51662-1248-1)
Marketing Start Date2018-08-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51662-1248-1 [51662124801]

PROMETHAZINE HCI INJECTION
Marketing CategoryANDA
Application NumberANDA083312
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-26
Inactivation Date2020-01-31
Reactivation Date2020-02-07

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE50 mg/mL

OpenFDA Data

SPL SET ID:744bcc7b-a1b3-1b72-e053-2a91aa0a7c3a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992858
  • Pharmacological Class

    • Phenothiazine [EPC]
    • Phenothiazines [CS]

    NDC Crossover Matching brand name "PROMETHAZINE HCI" or generic name "Promethazine Hci"

    NDCBrand NameGeneric Name
    51662-1247PROMETHAZINE HCIPROMETHAZINE HCI
    51662-1248PROMETHAZINE HCIPROMETHAZINE HCI

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