promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 12.5 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-875
Product ID 43063-875_415c4f6b-6dfe-2bc2-e063-6394a90ae1af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040712
Listing Expiration 2026-12-31
Marketing Start 2007-05-04

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063875
Hyphenated Format 43063-875

Supplemental Identifiers

RxCUI
992438
UPC
0343063875018
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 ANDA040712 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (43063-875-01)
source: ndc

Packages (1)

43063-875-01 100 TABLET in 1 BOTTLE, PLASTIC (43063-875-01)

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": "415c4f6b-6dfe-2bc2-e063-6394a90ae1af", "openfda": {"upc": ["0343063875018"], "unii": ["R61ZEH7I1I"], "rxcui": ["992438"], "spl_set_id": ["b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (43063-875-01)", "package_ndc": "43063-875-01", "marketing_start_date": "20180817"}], "brand_name": "PROMETHAZINE HYDROCHLORIDE", "product_id": "43063-875_415c4f6b-6dfe-2bc2-e063-6394a90ae1af", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "43063-875", "generic_name": "promethazine hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROMETHAZINE HYDROCHLORIDE", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA040712", "marketing_category": "ANDA", "marketing_start_date": "20070504", "listing_expiration_date": "20261231"}