promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 12.5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0989
Product ID 71335-0989_e2c0c4b9-d14f-4b7b-a98c-b3a7f78ec8d9
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 713350989
Hyphenated Format 71335-0989

Supplemental Identifiers

RxCUI
992438
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
  • 30 TABLET in 1 BOTTLE (71335-0989-0)
  • 12 TABLET in 1 BOTTLE (71335-0989-1)
  • 4 TABLET in 1 BOTTLE (71335-0989-2)
  • 2 TABLET in 1 BOTTLE (71335-0989-3)
  • 6 TABLET in 1 BOTTLE (71335-0989-5)
  • 10 TABLET in 1 BOTTLE (71335-0989-6)
  • 40 TABLET in 1 BOTTLE (71335-0989-7)
  • 20 TABLET in 1 BOTTLE (71335-0989-8)
  • 60 TABLET in 1 BOTTLE (71335-0989-9)
source: ndc

Packages (9)

71335-0989-0 30 TABLET in 1 BOTTLE (71335-0989-0) 71335-0989-1 12 TABLET in 1 BOTTLE (71335-0989-1) 71335-0989-2 4 TABLET in 1 BOTTLE (71335-0989-2) 71335-0989-3 2 TABLET in 1 BOTTLE (71335-0989-3) 71335-0989-5 6 TABLET in 1 BOTTLE (71335-0989-5) 71335-0989-6 10 TABLET in 1 BOTTLE (71335-0989-6) 71335-0989-7 40 TABLET in 1 BOTTLE (71335-0989-7) 71335-0989-8 20 TABLET in 1 BOTTLE (71335-0989-8) 71335-0989-9 60 TABLET in 1 BOTTLE (71335-0989-9)

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": "e2c0c4b9-d14f-4b7b-a98c-b3a7f78ec8d9", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992438"], "spl_set_id": ["f9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c47"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-0989-0)", "package_ndc": "71335-0989-0", "marketing_start_date": "20190103"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE (71335-0989-1)", "package_ndc": "71335-0989-1", "marketing_start_date": "20240709"}, {"sample": false, "description": "4 TABLET in 1 BOTTLE (71335-0989-2)", "package_ndc": "71335-0989-2", "marketing_start_date": "20240709"}, {"sample": false, "description": "2 TABLET in 1 BOTTLE (71335-0989-3)", "package_ndc": "71335-0989-3", "marketing_start_date": "20240709"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE (71335-0989-5)", "package_ndc": "71335-0989-5", "marketing_start_date": "20240709"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (71335-0989-6)", "package_ndc": "71335-0989-6", "marketing_start_date": "20211201"}, {"sample": false, "description": "40 TABLET in 1 BOTTLE (71335-0989-7)", "package_ndc": "71335-0989-7", "marketing_start_date": "20240709"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (71335-0989-8)", "package_ndc": "71335-0989-8", "marketing_start_date": "20240709"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-0989-9)", "package_ndc": "71335-0989-9", "marketing_start_date": "20181030"}], "brand_name": "PROMETHAZINE HYDROCHLORIDE", "product_id": "71335-0989_e2c0c4b9-d14f-4b7b-a98c-b3a7f78ec8d9", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "71335-0989", "generic_name": "promethazine hydrochloride", "labeler_name": "Bryant Ranch Prepack", "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"}