0591-5307

Generic: promethazine hydrochloride

Labeler: actavis pharma, inc.
NDC Directory DRUG FOR FURTHER PROCESSING DRUG FOR FURTHER PROCESSING Active

Drug Facts

Product Profile

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

promethazine hydrochloride 25 mg/1

Identifiers & Regulatory

Product NDC 0591-5307
Product ID 0591-5307_bdaf6cc3-7949-418d-9861-2c297a3748f3
Product Type DRUG FOR FURTHER PROCESSING
Marketing Category DRUG FOR FURTHER PROCESSING
Listing Expiration 2026-12-31
Marketing Start 1973-09-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05915307
Hyphenated Format 0591-5307

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: label)
Generic Name promethazine hydrochloride (source: ndc)
Application Number ANDA083426 (source: label)
Routes
oral
source: label

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 50000 TABLET in 1 BAG (0591-5307-00)
  • 60000 TABLET in 1 CONTAINER (0591-5307-77)
source: ndc

Packages (2)

0591-5307-00 50000 TABLET in 1 BAG (0591-5307-00) 0591-5307-77 60000 TABLET in 1 CONTAINER (0591-5307-77)

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 
{"spl_id": "bdaf6cc3-7949-418d-9861-2c297a3748f3", "openfda": {}, "finished": false, "packaging": [{"description": "50000 TABLET in 1 BAG (0591-5307-00)", "package_ndc": "0591-5307-00", "marketing_start_date": "19-SEP-73"}, {"description": "60000 TABLET in 1 CONTAINER (0591-5307-77)", "package_ndc": "0591-5307-77", "marketing_start_date": "19-SEP-24"}], "product_id": "0591-5307_bdaf6cc3-7949-418d-9861-2c297a3748f3", "dosage_form": "TABLET", "product_ndc": "0591-5307", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "DRUG FOR FURTHER PROCESSING", "brand_name_base": null, "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "marketing_category": "DRUG FOR FURTHER PROCESSING", "marketing_start_date": "19730919", "listing_expiration_date": "20261231"}