promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 12.5 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6216
Product ID 50090-6216_d8344fa6-6e74-4a25-a1fd-116487d02cb9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091179
Listing Expiration 2026-12-31
Marketing Start 2022-06-22

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500906216
Hyphenated Format 50090-6216

Supplemental Identifiers

RxCUI
992438
UNII
R61ZEH7I1I

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
  • 12.5 mg/1
source: ndc
Packaging
  • 21 TABLET in 1 BOTTLE (50090-6216-1)
source: ndc

Packages (1)

50090-6216-1 21 TABLET in 1 BOTTLE (50090-6216-1)

Ingredients (1)

promethazine hydrochloride (12.5 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": "d8344fa6-6e74-4a25-a1fd-116487d02cb9", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992438"], "spl_set_id": ["bf951b5b-6e38-44a9-895e-0d60c6b9d343"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "21 TABLET in 1 BOTTLE (50090-6216-1)", "package_ndc": "50090-6216-1", "marketing_start_date": "20221109"}], "brand_name": "Promethazine Hydrochloride", "product_id": "50090-6216_d8344fa6-6e74-4a25-a1fd-116487d02cb9", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "50090-6216", "generic_name": "Promethazine Hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA091179", "marketing_category": "ANDA", "marketing_start_date": "20220622", "listing_expiration_date": "20261231"}