58602-807 : Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Film Coated, Extended Release

NDC:	58602-807
Labeler:	Aurohealth LLC
Product Type:	Human OTC Drug
Drug Name:	Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Dosage Form:	Oral Tablet, Film Coated, Extended Release
Application #:	ANDA209116
Rev. Date:	Oct 30, 2017

Appearance:

Markings:	Z;79
Shapes:	Capsule
Colors:	Yellow
Size (mm):	19
Segments: ^*	1
^* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

58602-807-67: 2 BLISTER PACK IN 1 CARTON (58602‑807‑67) > 10 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BLISTER PACK
58602-807-83: 1 BLISTER PACK IN 1 CARTON (58602‑807‑83) > 10 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BLISTER PACK
58602-807-84: 3 BLISTER PACK IN 1 CARTON (58602‑807‑84) > 10 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BLISTER PACK

Active Ingredients:

Fexofenadine Hydrochloride
Pseudoephedrine Hydrochloride

Dosage Strength:

60 mg
120 mg

Inactive Ingredients:

Silicon Dioxide
Croscarmellose Sodium
Ferric Oxide Yellow
Hypromellose 2208 (100000 Mpa.s)
Microcrystalline Cellulose
Lactose Monohydrate
Hydroxypropyl Cellulose (200000 Mw)
Polyethylene Glycol 6000
Polyethylene Glycol 400
Starch, Corn
Stearic Acid

Pharmaceutical Classes:

Adrenergic alpha-Agonists [MoA]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
alpha-Adrenergic Agonist [EPC]

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.