promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: nostrum laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler nostrum laboratories, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

promethazine hydrochloride 6.25 mg/5mL

Manufacturer
Nostrum Laboratories, Inc.

Identifiers & Regulatory

Product NDC 29033-500
Product ID 29033-500_de4790d2-95c1-46e1-b8c6-f5bc14abcdbb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040891
Listing Expiration 2026-12-31
Marketing Start 2024-07-18

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 29033500
Hyphenated Format 29033-500

Supplemental Identifiers

RxCUI
992432
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 ANDA040891 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (29033-500-34)
source: ndc

Packages (1)

29033-500-34 473 mL in 1 BOTTLE (29033-500-34)

Ingredients (1)

promethazine hydrochloride (6.25 mg/5mL)

Linked Drug Pages (1)

PROMETHAZINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "de4790d2-95c1-46e1-b8c6-f5bc14abcdbb", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992432"], "spl_set_id": ["248cfe2a-deb1-4d7d-9f7f-15babee864bb"], "manufacturer_name": ["Nostrum Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (29033-500-34)", "package_ndc": "29033-500-34", "marketing_start_date": "20240718"}], "brand_name": "PROMETHAZINE HYDROCHLORIDE", "product_id": "29033-500_de4790d2-95c1-46e1-b8c6-f5bc14abcdbb", "dosage_form": "SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "29033-500", "generic_name": "PROMETHAZINE HYDROCHLORIDE", "labeler_name": "Nostrum Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROMETHAZINE HYDROCHLORIDE", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA040891", "marketing_category": "ANDA", "marketing_start_date": "20240718", "listing_expiration_date": "20261231"}