promethazine hydrochloride

Generic: promethazine hydrochloride

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

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 25 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1306
Product ID 70518-1306_48d44b37-74d6-edf5-e063-6394a90aa42b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040596
Listing Expiration 2027-12-31
Marketing Start 2018-07-16

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705181306
Hyphenated Format 70518-1306

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 ANDA040596 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE, PLASTIC (70518-1306-2)
  • 30 TABLET in 1 BLISTER PACK (70518-1306-4)
source: ndc

Packages (2)

70518-1306-2 15 TABLET in 1 BOTTLE, PLASTIC (70518-1306-2) 70518-1306-4 30 TABLET in 1 BLISTER PACK (70518-1306-4)

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": "48d44b37-74d6-edf5-e063-6394a90aa42b", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992447"], "spl_set_id": ["9e4e57fa-4ce3-4b7b-be5a-381801ed0386"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (70518-1306-2)", "package_ndc": "70518-1306-2", "marketing_start_date": "20201214"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-1306-4)", "package_ndc": "70518-1306-4", "marketing_start_date": "20230117"}], "brand_name": "Promethazine Hydrochloride", "product_id": "70518-1306_48d44b37-74d6-edf5-e063-6394a90aa42b", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "70518-1306", "generic_name": "Promethazine Hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA040596", "marketing_category": "ANDA", "marketing_start_date": "20180716", "listing_expiration_date": "20271231"}