promethazine

Generic: promethazine

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

Drug Facts

Product Profile

Brand Name promethazine
Generic Name promethazine
Labeler pharmpak, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 25 mg/1

Manufacturer
PharmPak, Inc.

Identifiers & Regulatory

Product NDC 54348-117
Product ID 54348-117_ea92baba-9184-5d68-e053-2a95a90a5e8f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040712
Listing Expiration 2026-12-31
Marketing Start 2019-07-11

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54348117
Hyphenated Format 54348-117

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 (source: ndc)
Generic Name promethazine (source: ndc)
Application Number ANDA040712 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (54348-117-00) / 1 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-117-02) / 2 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-117-03) / 3 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-117-04) / 4 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-117-05) / 5 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-117-06) / 6 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-117-08) / 8 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-117-09) / 9 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-117-10) / 10 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-117-12) / 12 TABLET in 1 BOTTLE
source: ndc

Packages (10)

54348-117-00 1 BOTTLE in 1 BOX (54348-117-00) / 1 TABLET in 1 BOTTLE 54348-117-02 1 BOTTLE in 1 BOX (54348-117-02) / 2 TABLET in 1 BOTTLE 54348-117-03 1 BOTTLE in 1 BOX (54348-117-03) / 3 TABLET in 1 BOTTLE 54348-117-04 1 BOTTLE in 1 BOX (54348-117-04) / 4 TABLET in 1 BOTTLE 54348-117-05 1 BOTTLE in 1 BOX (54348-117-05) / 5 TABLET in 1 BOTTLE 54348-117-06 1 BOTTLE in 1 BOX (54348-117-06) / 6 TABLET in 1 BOTTLE 54348-117-08 1 BOTTLE in 1 BOX (54348-117-08) / 8 TABLET in 1 BOTTLE 54348-117-09 1 BOTTLE in 1 BOX (54348-117-09) / 9 TABLET in 1 BOTTLE 54348-117-10 1 BOTTLE in 1 BOX (54348-117-10) / 10 TABLET in 1 BOTTLE 54348-117-12 1 BOTTLE in 1 BOX (54348-117-12) / 12 TABLET in 1 BOTTLE

Ingredients (1)

promethazine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Promethazine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ea92baba-9184-5d68-e053-2a95a90a5e8f", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992447"], "spl_set_id": ["4f681538-7ac4-484c-9e6d-b571d73b9e0b"], "manufacturer_name": ["PharmPak, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (54348-117-00)  / 1 TABLET in 1 BOTTLE", "package_ndc": "54348-117-00", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-117-02)  / 2 TABLET in 1 BOTTLE", "package_ndc": "54348-117-02", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-117-03)  / 3 TABLET in 1 BOTTLE", "package_ndc": "54348-117-03", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-117-04)  / 4 TABLET in 1 BOTTLE", "package_ndc": "54348-117-04", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-117-05)  / 5 TABLET in 1 BOTTLE", "package_ndc": "54348-117-05", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-117-06)  / 6 TABLET in 1 BOTTLE", "package_ndc": "54348-117-06", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-117-08)  / 8 TABLET in 1 BOTTLE", "package_ndc": "54348-117-08", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-117-09)  / 9 TABLET in 1 BOTTLE", "package_ndc": "54348-117-09", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-117-10)  / 10 TABLET in 1 BOTTLE", "package_ndc": "54348-117-10", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-117-12)  / 12 TABLET in 1 BOTTLE", "package_ndc": "54348-117-12", "marketing_start_date": "20190711"}], "brand_name": "Promethazine", "product_id": "54348-117_ea92baba-9184-5d68-e053-2a95a90a5e8f", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "54348-117", "generic_name": "PROMETHAZINE", "labeler_name": "PharmPak, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA040712", "marketing_category": "ANDA", "marketing_start_date": "20190711", "listing_expiration_date": "20261231"}