promethazine hydrochloride

Generic: promethazine hydrochloride

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

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 25 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4424
Product ID 68071-4424_2b36ea69-71a4-dc30-e063-6394a90a13f3
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 680714424
Hyphenated Format 68071-4424

Supplemental Identifiers

RxCUI
992447
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
  • 25 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (68071-4424-1)
  • 4 TABLET in 1 BOTTLE (68071-4424-4)
  • 6 TABLET in 1 BOTTLE (68071-4424-6)
source: ndc

Packages (3)

68071-4424-1 10 TABLET in 1 BOTTLE (68071-4424-1) 68071-4424-4 4 TABLET in 1 BOTTLE (68071-4424-4) 68071-4424-6 6 TABLET in 1 BOTTLE (68071-4424-6)

Ingredients (1)

promethazine hydrochloride (25 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": "2b36ea69-71a4-dc30-e063-6394a90a13f3", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992447"], "spl_set_id": ["6bcaa89f-5f14-dc45-e053-2a91aa0aac54"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (68071-4424-1)", "package_ndc": "68071-4424-1", "marketing_start_date": "20180509"}, {"sample": false, "description": "4 TABLET in 1 BOTTLE (68071-4424-4)", "package_ndc": "68071-4424-4", "marketing_start_date": "20180509"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE (68071-4424-6)", "package_ndc": "68071-4424-6", "marketing_start_date": "20180509"}], "brand_name": "PROMETHAZINE HYDROCHLORIDE", "product_id": "68071-4424_2b36ea69-71a4-dc30-e063-6394a90a13f3", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "68071-4424", "generic_name": "promethazine hydrochloride", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROMETHAZINE HYDROCHLORIDE", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA040712", "marketing_category": "ANDA", "marketing_start_date": "20060731", "listing_expiration_date": "20261231"}