promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler camber pharmaceuticals, inc.
Dosage Form SUPPOSITORY
Routes
RECTAL
Active Ingredients

promethazine hydrochloride 12.5 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-040
Product ID 31722-040_ecb3a4da-a4fc-7803-e053-2a95a90a0f3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216446
Listing Expiration 2026-12-31
Marketing Start 2022-11-02

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722040
Hyphenated Format 31722-040

Supplemental Identifiers

RxCUI
992441 992454
UPC
0331722040310 0331722041317
UNII
R61ZEH7I1I

Packaging Origin

Original Packager
true

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 ANDA216446 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (31722-040-31) / 6 SUPPOSITORY in 1 BLISTER PACK
source: ndc

Packages (1)

31722-040-31 2 BLISTER PACK in 1 CARTON (31722-040-31) / 6 SUPPOSITORY in 1 BLISTER PACK

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": ["RECTAL"], "spl_id": "ecb3a4da-a4fc-7803-e053-2a95a90a0f3f", "openfda": {"upc": ["0331722040310", "0331722041317"], "unii": ["R61ZEH7I1I"], "rxcui": ["992441", "992454"], "spl_set_id": ["ba7d9e82-9b13-4607-b2f9-25e575b8c73b"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (31722-040-31)  / 6 SUPPOSITORY in 1 BLISTER PACK", "package_ndc": "31722-040-31", "marketing_start_date": "20221102"}], "brand_name": "Promethazine Hydrochloride", "product_id": "31722-040_ecb3a4da-a4fc-7803-e053-2a95a90a0f3f", "dosage_form": "SUPPOSITORY", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "31722-040", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA216446", "marketing_category": "ANDA", "marketing_start_date": "20221102", "listing_expiration_date": "20261231"}