Home NDC 42254-359 nasal decongestant
Product NDC 42254-359
11-digit product format 422540359
Labeler code 42254
Product ID 42254-359_83ae6177-afbb-477f-a5ff-64d48960ffef
Type HUMAN OTC DRUG
Nonproprietary name Pseudoephedrine Hydrochloride
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Rebel Distributors Corp
Application ANDA075153
Marketing category ANDA
Marketing start 1999-08-12
Marketing end 0000-00-00
Substance PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 120 mg/1
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42254-359-10 nasal decongestant 1 in 1 CARTON TABLET, FILM COATED, EXTENDED RE 1 1 42254-359-10 nasal decongestant 10 in 1 BLISTER PACK TABLET, FILM COATED, EXTENDED RE 10 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42254-359 NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 2 package rows 20130329_83ae6177-afbb-477f-a5ff-64d48960ffef.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 42254-359-10 42254035910 1 in 1 CARTON Historical