promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 25 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-521
Product ID 53746-521_91a3c41d-efc8-4caa-8cec-1976ac46c000
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091179
Listing Expiration 2027-12-31
Marketing Start 2022-06-22

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746521
Hyphenated Format 53746-521

Supplemental Identifiers

RxCUI
992438 992447 992475
UPC
0353746522016
UNII
R61ZEH7I1I

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name promethazine hydrochloride (source: ndc)
Generic Name promethazine hydrochloride (source: ndc)
Application Number ANDA091179 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (53746-521-01)
  • 1000 TABLET in 1 BOTTLE (53746-521-10)
source: ndc

Packages (2)

53746-521-01 100 TABLET in 1 BOTTLE (53746-521-01) 53746-521-10 1000 TABLET in 1 BOTTLE (53746-521-10)

Ingredients (1)

promethazine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Promethazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "91a3c41d-efc8-4caa-8cec-1976ac46c000", "openfda": {"upc": ["0353746522016"], "unii": ["R61ZEH7I1I"], "rxcui": ["992438", "992447", "992475"], "spl_set_id": ["0b5734b8-6a52-44ff-ac29-9a91a4335394"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53746-521-01)", "package_ndc": "53746-521-01", "marketing_start_date": "20220622"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (53746-521-10)", "package_ndc": "53746-521-10", "marketing_start_date": "20220622"}], "brand_name": "Promethazine Hydrochloride", "product_id": "53746-521_91a3c41d-efc8-4caa-8cec-1976ac46c000", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "53746-521", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA091179", "marketing_category": "ANDA", "marketing_start_date": "20220622", "listing_expiration_date": "20271231"}