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 43063-405
Product ID 43063-405_2b25978a-386b-0df6-e063-6394a90aa28d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091179
Listing Expiration 2026-12-31
Marketing Start 2011-03-03

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063405
Hyphenated Format 43063-405

Supplemental Identifiers

RxCUI
992447
UPC
0343063405055
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 ANDA091179 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1 TABLET in 1 BOTTLE, PLASTIC (43063-405-01)
  • 2 TABLET in 1 BOTTLE, PLASTIC (43063-405-02)
  • 4 TABLET in 1 BOTTLE, PLASTIC (43063-405-04)
  • 5 TABLET in 1 BOTTLE, PLASTIC (43063-405-05)
  • 6 TABLET in 1 BOTTLE, PLASTIC (43063-405-06)
  • 10 TABLET in 1 BOTTLE, PLASTIC (43063-405-10)
  • 12 TABLET in 1 BOTTLE, PLASTIC (43063-405-12)
  • 15 TABLET in 1 BOTTLE, PLASTIC (43063-405-15)
  • 20 TABLET in 1 BOTTLE, PLASTIC (43063-405-20)
  • 25 TABLET in 1 BOTTLE, PLASTIC (43063-405-25)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-405-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-405-60)
  • 1 TABLET in 1 BOTTLE, PLASTIC (43063-405-79)
source: ndc

Packages (13)

43063-405-01 1 TABLET in 1 BOTTLE, PLASTIC (43063-405-01) 43063-405-02 2 TABLET in 1 BOTTLE, PLASTIC (43063-405-02) 43063-405-04 4 TABLET in 1 BOTTLE, PLASTIC (43063-405-04) 43063-405-05 5 TABLET in 1 BOTTLE, PLASTIC (43063-405-05) 43063-405-06 6 TABLET in 1 BOTTLE, PLASTIC (43063-405-06) 43063-405-10 10 TABLET in 1 BOTTLE, PLASTIC (43063-405-10) 43063-405-12 12 TABLET in 1 BOTTLE, PLASTIC (43063-405-12) 43063-405-15 15 TABLET in 1 BOTTLE, PLASTIC (43063-405-15) 43063-405-20 20 TABLET in 1 BOTTLE, PLASTIC (43063-405-20) 43063-405-25 25 TABLET in 1 BOTTLE, PLASTIC (43063-405-25) 43063-405-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-405-30) 43063-405-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-405-60) 43063-405-79 1 TABLET in 1 BOTTLE, PLASTIC (43063-405-79)

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": "2b25978a-386b-0df6-e063-6394a90aa28d", "openfda": {"upc": ["0343063405055"], "unii": ["R61ZEH7I1I"], "rxcui": ["992447"], "spl_set_id": ["81fd29a9-c090-49ba-8b48-bd3656ca0c92"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TABLET in 1 BOTTLE, PLASTIC (43063-405-01)", "package_ndc": "43063-405-01", "marketing_start_date": "20120221"}, {"sample": false, "description": "2 TABLET in 1 BOTTLE, PLASTIC (43063-405-02)", "package_ndc": "43063-405-02", "marketing_start_date": "20120221"}, {"sample": false, "description": "4 TABLET in 1 BOTTLE, PLASTIC (43063-405-04)", "package_ndc": "43063-405-04", "marketing_start_date": "20120221"}, {"sample": false, "description": "5 TABLET in 1 BOTTLE, PLASTIC (43063-405-05)", "package_ndc": "43063-405-05", "marketing_start_date": "20120221"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE, PLASTIC (43063-405-06)", "package_ndc": "43063-405-06", "marketing_start_date": "20120221"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (43063-405-10)", "package_ndc": "43063-405-10", "marketing_start_date": "20120221"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE, PLASTIC (43063-405-12)", "package_ndc": "43063-405-12", "marketing_start_date": "20120221"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (43063-405-15)", "package_ndc": "43063-405-15", "marketing_start_date": "20120221"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (43063-405-20)", "package_ndc": "43063-405-20", "marketing_start_date": "20120221"}, {"sample": false, "description": "25 TABLET in 1 BOTTLE, PLASTIC (43063-405-25)", "package_ndc": "43063-405-25", "marketing_start_date": "20120221"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-405-30)", "package_ndc": "43063-405-30", "marketing_start_date": "20120221"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-405-60)", "package_ndc": "43063-405-60", "marketing_start_date": "20120221"}, {"sample": false, "description": "1 TABLET in 1 BOTTLE, PLASTIC (43063-405-79)", "package_ndc": "43063-405-79", "marketing_start_date": "20120221"}], "brand_name": "Promethazine Hydrochloride", "product_id": "43063-405_2b25978a-386b-0df6-e063-6394a90aa28d", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "43063-405", "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": "ANDA091179", "marketing_category": "ANDA", "marketing_start_date": "20110303", "listing_expiration_date": "20261231"}