NDC 61919-773

OMEPRAZOLE DR

Omeprazole Dr

OMEPRAZOLE DR is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Omeprazole.

• Product ID: 61919-773_4144b16e-5027-009d-e054-00144ff88e88
• NDC: 61919-773
• Product Type: Human Prescription Drug
• Proprietary Name: OMEPRAZOLE DR
• Generic Name: Omeprazole Dr
• Dosage Form: Capsule, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2015-01-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076048
• Labeler Name: Direct Rx
• Substance Name: OMEPRAZOLE
• Active Ingredient Strength: 40 mg/1
• Pharm Classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 61919-773-30

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-773-30)

• Marketing Start Date: 2017-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-773-30 [61919077330]

OMEPRAZOLE DR CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076048
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-01-01

NDC 61919-773-60 [61919077360]

OMEPRAZOLE DR CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076048
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-01-01
• Marketing End Date: 2020-01-30

Drug Details

Active Ingredients

Ingredient	Strength
OMEPRAZOLE	40 mg/1

OpenFDA Data

• SPL SET ID: c6bc8fb7-2862-464a-b7c9-e409034f072a
• Manufacturer:
  • Direct Rx
• UNII:
  • KG60484QX9
• RxNorm Concept Unique ID - RxCUI:
  • 200329
  • 198051

Pharmacological Class

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

NDC Crossover Matching brand name "OMEPRAZOLE DR" or generic name "Omeprazole Dr"

NDC	Brand Name	Generic Name
61919-176	OMEPRAZOLE DR	OMEPRAZOLE DR
61919-773	OMEPRAZOLE DR	OMEPRAZOLE DR
61919-807	OMEPRAZOLE DR	OMEPRAZOLE DR
51655-022	OMEPRAZOLE	OMEPRAZOLE DR