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 SUPPOSITORY
Routes
RECTAL
Active Ingredients

promethazine hydrochloride 25 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-060
Product ID 43063-060_41372747-70d1-1b51-e063-6294a90aef1f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040500
Listing Expiration 2026-12-31
Marketing Start 2006-05-17

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063060
Hyphenated Format 43063-060

Supplemental Identifiers

RxCUI
992454
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 ANDA040500 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 2 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-02)
  • 4 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-04)
  • 6 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-06)
source: ndc

Packages (3)

43063-060-02 2 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-02) 43063-060-04 4 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-04) 43063-060-06 6 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-06)

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": ["RECTAL"], "spl_id": "41372747-70d1-1b51-e063-6294a90aef1f", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992454"], "spl_set_id": ["7d766cf7-a21c-4eaf-bbdc-00f2939ef19a"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "2 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-02)", "package_ndc": "43063-060-02", "marketing_start_date": "20110328"}, {"sample": false, "description": "4 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-04)", "package_ndc": "43063-060-04", "marketing_start_date": "20110328"}, {"sample": false, "description": "6 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-06)", "package_ndc": "43063-060-06", "marketing_start_date": "20110328"}], "brand_name": "Promethazine Hydrochloride", "product_id": "43063-060_41372747-70d1-1b51-e063-6294a90aef1f", "dosage_form": "SUPPOSITORY", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "43063-060", "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": "ANDA040500", "marketing_category": "ANDA", "marketing_start_date": "20060517", "listing_expiration_date": "20261231"}