promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: quagen pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler quagen pharmaceuticals llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

promethazine hydrochloride 6.25 mg/5mL

Manufacturer
QUAGEN PHARMACEUTICALS LLC

Identifiers & Regulatory

Product NDC 70752-138
Product ID 70752-138_63b61b41-3490-4c96-a50d-778498b51899
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213890
Listing Expiration 2026-12-31
Marketing Start 2021-07-12

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70752138
Hyphenated Format 70752-138

Supplemental Identifiers

RxCUI
992432
UPC
0370752138123
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 ANDA213890 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE, PLASTIC (70752-138-06)
  • 473 mL in 1 BOTTLE, PLASTIC (70752-138-12)
source: ndc

Packages (2)

70752-138-06 118 mL in 1 BOTTLE, PLASTIC (70752-138-06) 70752-138-12 473 mL in 1 BOTTLE, PLASTIC (70752-138-12)

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": "63b61b41-3490-4c96-a50d-778498b51899", "openfda": {"upc": ["0370752138123"], "unii": ["R61ZEH7I1I"], "rxcui": ["992432"], "spl_set_id": ["32022e66-6f76-430a-8ad2-1e9e2872fee1"], "manufacturer_name": ["QUAGEN PHARMACEUTICALS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (70752-138-06)", "package_ndc": "70752-138-06", "marketing_start_date": "20210712"}, {"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (70752-138-12)", "package_ndc": "70752-138-12", "marketing_start_date": "20210712"}], "brand_name": "Promethazine Hydrochloride", "product_id": "70752-138_63b61b41-3490-4c96-a50d-778498b51899", "dosage_form": "SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "70752-138", "generic_name": "Promethazine Hydrochloride", "labeler_name": "QUAGEN PHARMACEUTICALS LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA213890", "marketing_category": "ANDA", "marketing_start_date": "20210712", "listing_expiration_date": "20261231"}