50090-2548 : Ibuprofen 800 mg Oral Tablet, Film Coated

NDC:	50090-2548
Labeler:	A-s Medication Solutions
Product Type:	Human Prescription Drug
Drug Name:	Ibuprofen
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA091625
Rev. Date:	Dec 21, 2015

Appearance:

Markings:	I;10
Shapes:	Oval
Colors:	White
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:

50090-2548-0: 10 TABLET, FILM COATED IN 1 BOTTLE (50090‑2548‑0)
50090-2548-1: 15 TABLET, FILM COATED IN 1 BOTTLE (50090‑2548‑1)
50090-2548-2: 30 TABLET, FILM COATED IN 1 BOTTLE (50090‑2548‑2)
50090-2548-3: 45 TABLET, FILM COATED IN 1 BOTTLE (50090‑2548‑3)
50090-2548-4: 60 TABLET, FILM COATED IN 1 BOTTLE (50090‑2548‑4)
50090-2548-5: 100 TABLET, FILM COATED IN 1 BOTTLE (50090‑2548‑5)
50090-2548-7: 21 TABLET, FILM COATED IN 1 BOTTLE (50090‑2548‑7)
50090-2548-8: 12 TABLET, FILM COATED IN 1 BOTTLE (50090‑2548‑8)
50090-2548-9: 40 TABLET, FILM COATED IN 1 BOTTLE (50090‑2548‑9)

Active Ingredients:

Ibuprofen

Dosage Strength:

800 mg

Inactive Ingredients:

Silicon Dioxide
Croscarmellose Sodium
Hydroxypropyl Cellulose (1200000 Mw)
Magnesium Stearate
Microcrystalline Cellulose
Polyethylene Glycol 400
Povidone K90
Sodium Lauryl Sulfate
Titanium Dioxide
Starch, Corn
Hypromellose 2910 (3 Mpa.s)
Hypromellose 2910 (5 Mpa.s)
Hypromellose 2910 (6 Mpa.s)
Water

Pharmaceutical Classes:

Cyclooxygenase Inhibitors [MoA]
Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
Nonsteroidal Anti-inflammatory Drug [EPC]

NDC QR Code

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NDC 50090-2548 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.