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 50 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-876
Product ID 43063-876_415c5df8-a775-c991-e063-6394a90a1f47
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040712
Listing Expiration 2026-12-31
Marketing Start 2006-07-31

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063876
Hyphenated Format 43063-876

Supplemental Identifiers

RxCUI
992475
UPC
0343063876015
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
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (43063-876-01)
  • 4 TABLET in 1 BOTTLE, PLASTIC (43063-876-04)
source: ndc

Packages (2)

43063-876-01 100 TABLET in 1 BOTTLE, PLASTIC (43063-876-01) 43063-876-04 4 TABLET in 1 BOTTLE, PLASTIC (43063-876-04)

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": "415c5df8-a775-c991-e063-6394a90a1f47", "openfda": {"upc": ["0343063876015"], "unii": ["R61ZEH7I1I"], "rxcui": ["992475"], "spl_set_id": ["f93ca67d-362a-473f-8296-2952da77c074"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (43063-876-01)", "package_ndc": "43063-876-01", "marketing_start_date": "20180717"}, {"sample": false, "description": "4 TABLET in 1 BOTTLE, PLASTIC (43063-876-04)", "package_ndc": "43063-876-04", "marketing_start_date": "20181207"}], "brand_name": "PROMETHAZINE HYDROCHLORIDE", "product_id": "43063-876_415c5df8-a775-c991-e063-6394a90a1f47", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "43063-876", "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": "50 mg/1"}], "application_number": "ANDA040712", "marketing_category": "ANDA", "marketing_start_date": "20060731", "listing_expiration_date": "20261231"}