promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

promethazine hydrochloride 25 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-874
Product ID 43063-874_42c82d4c-6de9-3766-e063-6394a90a10ff
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 43063874
Hyphenated Format 43063-874

Supplemental Identifiers

RxCUI
992447
UPC
0343063874011
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
  • 100 TABLET in 1 BOTTLE, PLASTIC (43063-874-01)
  • 2 TABLET in 1 BOTTLE, PLASTIC (43063-874-02)
  • 4 TABLET in 1 BOTTLE, PLASTIC (43063-874-04)
  • 5 TABLET in 1 BOTTLE, PLASTIC (43063-874-05)
  • 6 TABLET in 1 BOTTLE, PLASTIC (43063-874-06)
  • 10 TABLET in 1 BOTTLE, PLASTIC (43063-874-10)
  • 12 TABLET in 1 BOTTLE, PLASTIC (43063-874-12)
  • 15 TABLET in 1 BOTTLE, PLASTIC (43063-874-15)
  • 20 TABLET in 1 BOTTLE, PLASTIC (43063-874-20)
  • 25 TABLET in 1 BOTTLE, PLASTIC (43063-874-25)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-874-30)
  • 1 TABLET in 1 BOTTLE, PLASTIC (43063-874-79)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (43063-874-95)
source: ndc

Packages (13)

43063-874-01 100 TABLET in 1 BOTTLE, PLASTIC (43063-874-01) 43063-874-02 2 TABLET in 1 BOTTLE, PLASTIC (43063-874-02) 43063-874-04 4 TABLET in 1 BOTTLE, PLASTIC (43063-874-04) 43063-874-05 5 TABLET in 1 BOTTLE, PLASTIC (43063-874-05) 43063-874-06 6 TABLET in 1 BOTTLE, PLASTIC (43063-874-06) 43063-874-10 10 TABLET in 1 BOTTLE, PLASTIC (43063-874-10) 43063-874-12 12 TABLET in 1 BOTTLE, PLASTIC (43063-874-12) 43063-874-15 15 TABLET in 1 BOTTLE, PLASTIC (43063-874-15) 43063-874-20 20 TABLET in 1 BOTTLE, PLASTIC (43063-874-20) 43063-874-25 25 TABLET in 1 BOTTLE, PLASTIC (43063-874-25) 43063-874-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-874-30) 43063-874-79 1 TABLET in 1 BOTTLE, PLASTIC (43063-874-79) 43063-874-95 1000 TABLET in 1 BOTTLE, PLASTIC (43063-874-95)

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": "42c82d4c-6de9-3766-e063-6394a90a10ff", "openfda": {"upc": ["0343063874011"], "unii": ["R61ZEH7I1I"], "rxcui": ["992447"], "spl_set_id": ["5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (43063-874-01)", "package_ndc": "43063-874-01", "marketing_start_date": "20180816"}, {"sample": false, "description": "2 TABLET in 1 BOTTLE, PLASTIC (43063-874-02)", "package_ndc": "43063-874-02", "marketing_start_date": "20191111"}, {"sample": false, "description": "4 TABLET in 1 BOTTLE, PLASTIC (43063-874-04)", "package_ndc": "43063-874-04", "marketing_start_date": "20180827"}, {"sample": false, "description": "5 TABLET in 1 BOTTLE, PLASTIC (43063-874-05)", "package_ndc": "43063-874-05", "marketing_start_date": "20180906"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE, PLASTIC (43063-874-06)", "package_ndc": "43063-874-06", "marketing_start_date": "20180827"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (43063-874-10)", "package_ndc": "43063-874-10", "marketing_start_date": "20180730"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE, PLASTIC (43063-874-12)", "package_ndc": "43063-874-12", "marketing_start_date": "20180820"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (43063-874-15)", "package_ndc": "43063-874-15", "marketing_start_date": "20180820"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (43063-874-20)", "package_ndc": "43063-874-20", "marketing_start_date": "20181207"}, {"sample": false, "description": "25 TABLET in 1 BOTTLE, PLASTIC (43063-874-25)", "package_ndc": "43063-874-25", "marketing_start_date": "20251104"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-874-30)", "package_ndc": "43063-874-30", "marketing_start_date": "20180905"}, {"sample": false, "description": "1 TABLET in 1 BOTTLE, PLASTIC (43063-874-79)", "package_ndc": "43063-874-79", "marketing_start_date": "20191107"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (43063-874-95)", "package_ndc": "43063-874-95", "marketing_start_date": "20180817"}], "brand_name": "PROMETHAZINE HYDROCHLORIDE", "product_id": "43063-874_42c82d4c-6de9-3766-e063-6394a90a10ff", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "43063-874", "generic_name": "promethazine hydrochloride", "labeler_name": "PD-Rx 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"}