sinus 12 hour

Generic: pseudoephedrine hcl

Labeler: l. perrigo company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sinus 12 hour
Generic Name pseudoephedrine hcl
Labeler l. perrigo company
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

pseudoephedrine hydrochloride 120 mg/1

Manufacturer
L. Perrigo Company

Identifiers & Regulatory

Product NDC 0113-2017
Product ID 0113-2017_98b199af-35e9-4582-9d3f-129d0696172f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075153
Listing Expiration 2026-12-31
Marketing Start 2017-09-29

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01132017
Hyphenated Format 0113-2017

Supplemental Identifiers

RxCUI
1049154
UNII
6V9V2RYJ8N

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 sinus 12 hour (source: ndc)
Generic Name pseudoephedrine hcl (source: ndc)
Application Number ANDA075153 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 CARTON (0113-2017-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

0113-2017-60 20 BLISTER PACK in 1 CARTON (0113-2017-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

pseudoephedrine hydrochloride (120 mg/1)

Linked Drug Pages (1)

sinus 12 hour ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "98b199af-35e9-4582-9d3f-129d0696172f", "openfda": {"unii": ["6V9V2RYJ8N"], "rxcui": ["1049154"], "spl_set_id": ["26206f75-648f-47c9-8bad-25127c33961d"], "manufacturer_name": ["L. Perrigo Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 CARTON (0113-2017-60)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0113-2017-60", "marketing_start_date": "20170929"}], "brand_name": "sinus 12 hour", "product_id": "0113-2017_98b199af-35e9-4582-9d3f-129d0696172f", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "0113-2017", "generic_name": "Pseudoephedrine HCl", "labeler_name": "L. Perrigo Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "sinus 12 hour", "active_ingredients": [{"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA075153", "marketing_category": "ANDA", "marketing_start_date": "20170929", "listing_expiration_date": "20261231"}