NDC 51662-1247

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 ID: 51662-1247_7447e8c6-c199-cd2d-e053-2a91aa0a3895
• NDC: 51662-1247
• Product Type: Human Prescription Drug
• Proprietary Name: PROMETHAZINE HCI
• Generic Name: Promethazine Hci
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2018-08-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA083312
• Labeler Name: HF Acquisition Co. LLC, DBA HealthFirst
• Substance Name: PROMETHAZINE HYDROCHLORIDE
• Active Ingredient Strength: 25 mg/mL
• Pharm Classes: Phenothiazine [EPC],Phenothiazines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 51662-1247-1

1 mL in 1 VIAL, SINGLE-DOSE (51662-1247-1)

• Marketing Start Date: 2018-08-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51662-1247-1 [51662124701]

PROMETHAZINE HCI INJECTION

• Marketing Category: ANDA
• Application Number: ANDA083312
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-08-26
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-07

Drug Details

Active Ingredients

Ingredient	Strength
PROMETHAZINE HYDROCHLORIDE	25 mg/mL

OpenFDA Data

• SPL SET ID: 7447e8c6-c198-cd2d-e053-2a91aa0a3895
• Manufacturer:
  • HF Acquisition Co. LLC, DBA HealthFirst
• UNII:
  • R61ZEH7I1I
• RxNorm Concept Unique ID - RxCUI:
  • 992460

Pharmacological Class

• Phenothiazine [EPC]
• Phenothiazines [CS]

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

NDC	Brand Name	Generic Name
51662-1247	PROMETHAZINE HCI	PROMETHAZINE HCI
51662-1248	PROMETHAZINE HCI	PROMETHAZINE HCI