promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: kvk-tech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler kvk-tech, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 25 mg/1

Manufacturer
KVK-Tech, Inc.

Identifiers & Regulatory

Product NDC 10702-003
Product ID 10702-003_17529733-d03d-6be0-e063-6294a90a99bf
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 10702003
Hyphenated Format 10702-003

Supplemental Identifiers

RxCUI
992438 992447 992475
UNII
R61ZEH7I1I

Packaging Origin

Original Packager
true

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 (10702-003-01)
  • 1000 TABLET in 1 BOTTLE (10702-003-10)
  • 500 TABLET in 1 BOTTLE (10702-003-50)
source: ndc

Packages (3)

10702-003-01 100 TABLET in 1 BOTTLE (10702-003-01) 10702-003-10 1000 TABLET in 1 BOTTLE (10702-003-10) 10702-003-50 500 TABLET in 1 BOTTLE (10702-003-50)

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": "17529733-d03d-6be0-e063-6294a90a99bf", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992438", "992447", "992475"], "spl_set_id": ["7a137adf-39b7-4b14-80da-c3cac9ad562a"], "manufacturer_name": ["KVK-Tech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (10702-003-01)", "package_ndc": "10702-003-01", "marketing_start_date": "20060731"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (10702-003-10)", "package_ndc": "10702-003-10", "marketing_start_date": "20060731"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (10702-003-50)", "package_ndc": "10702-003-50", "marketing_start_date": "20160519"}], "brand_name": "PROMETHAZINE HYDROCHLORIDE", "product_id": "10702-003_17529733-d03d-6be0-e063-6294a90a99bf", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "10702-003", "generic_name": "promethazine hydrochloride", "labeler_name": "KVK-Tech, 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"}