promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler actavis pharma, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 50 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-5319
Product ID 0591-5319_4ad005c9-31b6-4232-995f-920d1839256e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA083711
Listing Expiration 2026-12-31
Marketing Start 1973-09-21

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05915319
Hyphenated Format 0591-5319

Supplemental Identifiers

RxCUI
992447 992475
UPC
0305915319019 0305915307016
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 ANDA083711 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0591-5319-01)
source: ndc

Packages (1)

0591-5319-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-5319-01)

Ingredients (1)

promethazine hydrochloride (50 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": "4ad005c9-31b6-4232-995f-920d1839256e", "openfda": {"upc": ["0305915319019", "0305915307016"], "unii": ["R61ZEH7I1I"], "rxcui": ["992447", "992475"], "spl_set_id": ["a32255f0-0077-489e-bdc6-869aca8cd434"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0591-5319-01)", "package_ndc": "0591-5319-01", "marketing_start_date": "19730921"}], "brand_name": "Promethazine Hydrochloride", "product_id": "0591-5319_4ad005c9-31b6-4232-995f-920d1839256e", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "0591-5319", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA083711", "marketing_category": "ANDA", "marketing_start_date": "19730921", "listing_expiration_date": "20261231"}