chlorphen-12

Generic: chlorpheniramine maleate

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

Drug Facts

Product Profile

Brand Name chlorphen-12
Generic Name chlorpheniramine maleate
Labeler kvk-tech, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

chlorpheniramine maleate 12 mg/1

Manufacturer
KVK-Tech, Inc.

Identifiers & Regulatory

Product NDC 10702-017
Product ID 10702-017_7d67f785-a25f-1819-e053-2991aa0a11d3
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA040829
Listing Expiration 2026-12-31
Marketing Start 2010-06-15

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10702017
Hyphenated Format 10702-017

Supplemental Identifiers

RxCUI
1363288
UPC
0310702017061
UNII
V1Q0O9OJ9Z

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 chlorphen-12 (source: ndc)
Generic Name chlorpheniramine maleate (source: ndc)
Application Number ANDA040829 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10702-017-01)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10702-017-06)
  • 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (10702-017-24)
  • 50 PACKAGE in 1 CARTON (10702-017-54) / 4 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (10702-017-04)
source: ndc

Packages (4)

10702-017-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10702-017-01) 10702-017-06 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10702-017-06) 10702-017-24 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (10702-017-24) 10702-017-54 50 PACKAGE in 1 CARTON (10702-017-54) / 4 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (10702-017-04)

Ingredients (1)

chlorpheniramine maleate (12 mg/1)

Linked Drug Pages (1)

Chlorphen-12 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7d67f785-a25f-1819-e053-2991aa0a11d3", "openfda": {"upc": ["0310702017061"], "unii": ["V1Q0O9OJ9Z"], "rxcui": ["1363288"], "spl_set_id": ["84409269-fe9b-469e-9a66-27b1475231a3"], "manufacturer_name": ["KVK-Tech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10702-017-01)", "package_ndc": "10702-017-01", "marketing_start_date": "20100615"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10702-017-06)", "package_ndc": "10702-017-06", "marketing_start_date": "20100615"}, {"sample": false, "description": "24 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (10702-017-24)", "package_ndc": "10702-017-24", "marketing_start_date": "20100615"}, {"sample": false, "description": "50 PACKAGE in 1 CARTON (10702-017-54)  / 4 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (10702-017-04)", "package_ndc": "10702-017-54", "marketing_start_date": "20181129"}], "brand_name": "Chlorphen-12", "product_id": "10702-017_7d67f785-a25f-1819-e053-2991aa0a11d3", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "10702-017", "generic_name": "Chlorpheniramine Maleate", "labeler_name": "KVK-Tech, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Chlorphen-12", "active_ingredients": [{"name": "CHLORPHENIRAMINE MALEATE", "strength": "12 mg/1"}], "application_number": "ANDA040829", "marketing_category": "ANDA", "marketing_start_date": "20100615", "listing_expiration_date": "20261231"}