63629-3643 : Omeprazole 10 mg Oral Capsule, Delayed Release

NDC:	63629-3643
Labeler:	Bryant Ranch Prepack
Product Type:	Human Prescription Drug
Drug Name:	Omeprazole
Dosage Form:	Oral Capsule, Delayed Release
Application #:	ANDA075576
Rev. Date:	Jan 21, 2009

Appearance:

Markings:	Omeprazole;10mg;R157
Shapes:	Capsule
Colors:	White
Size (mm):	14
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:

63629-3643-1: 60 CAPSULE, DELAYED RELEASE IN 1 BOTTLE (63629‑3643‑1)
63629-3643-2: 30 CAPSULE, DELAYED RELEASE IN 1 BOTTLE (63629‑3643‑2)
63629-3643-3: 90 CAPSULE, DELAYED RELEASE IN 1 BOTTLE (63629‑3643‑3)

Active Ingredients:

Omeprazole

Dosage Strength:

10 mg

Inactive Ingredients:

Crospovidone (15 Mpa.s At 5%)
Hypromellose, Unspecified
Magnesium Stearate
Mannitol
Meglumine
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
Shellac
Poloxamer 407
Povidone, Unspecified
Triethyl Citrate
D&c Red No. 28
Fd&c Blue No. 1
Fd&c Red No. 40
Fd&c Yellow No. 6
Ferric Oxide Yellow
Gelatin, Unspecified
Silicon Dioxide
Sodium Lauryl Sulfate
Titanium Dioxide
Butyl Alcohol
Propylene Glycol

Pharmaceutical Classes:

Proton Pump Inhibitor [EPC]
Proton Pump Inhibitors [MoA]
Cytochrome P450 2C19 Inhibitors [MoA]

NDC QR Code

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NDC 63629-3643 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.