promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 12.5 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-660
Product ID 60687-660_437eb3f4-c605-1e34-e063-6294a90aba73
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040596
Listing Expiration 2026-12-31
Marketing Start 2022-06-20

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687660
Hyphenated Format 60687-660

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 ANDA040596 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (60687-660-01) / 1 TABLET in 1 BLISTER PACK (60687-660-11)
source: ndc

Packages (1)

60687-660-01 100 BLISTER PACK in 1 CARTON (60687-660-01) / 1 TABLET in 1 BLISTER PACK (60687-660-11)

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": "437eb3f4-c605-1e34-e063-6294a90aba73", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992438"], "spl_set_id": ["57b4bf23-c563-4357-9dcf-066cbc1280e4"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (60687-660-01)  / 1 TABLET in 1 BLISTER PACK (60687-660-11)", "package_ndc": "60687-660-01", "marketing_start_date": "20220620"}], "brand_name": "Promethazine Hydrochloride", "product_id": "60687-660_437eb3f4-c605-1e34-e063-6294a90aba73", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "60687-660", "generic_name": "Promethazine Hydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA040596", "marketing_category": "ANDA", "marketing_start_date": "20220620", "listing_expiration_date": "20261231"}