NDC 61919-807

OMEPRAZOLE DR

Omeprazole

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

Product ID61919-807_87e91beb-e8ee-17ac-e053-2995a90a4ba8
NDC61919-807
Product TypeHuman Prescription Drug
Proprietary NameOMEPRAZOLE DR
Generic NameOmeprazole
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-05-02
Marketing CategoryANDA / ANDA
Application NumberANDA091672
Labeler NameDirexctRX
Substance NameOMEPRAZOLE
Active Ingredient Strength20 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61919-807-15

15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-807-15)
Marketing Start Date2019-05-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-807-60 [61919080760]

OMEPRAZOLE DR CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091672
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-02

NDC 61919-807-15 [61919080715]

OMEPRAZOLE DR CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091672
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-02

NDC 61919-807-90 [61919080790]

OMEPRAZOLE DR CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091672
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-02

NDC 61919-807-30 [61919080730]

OMEPRAZOLE DR CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091672
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-02

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

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"

NDCBrand NameGeneric Name
51655-022OMEPRAZOLE DROMEPRAZOLE DR
61919-176OMEPRAZOLE DROMEPRAZOLE DR
61919-773OMEPRAZOLE DROMEPRAZOLE DR
61919-807OMEPRAZOLE DROMEPRAZOLE DR
0363-1008Acid ReducerOmeprazole
0536-1322Acid ReducerOmeprazole
0113-7401Basic Care OmeprazoleOmeprazole
0113-7520basic care omeprazoleomeprazole
0113-7915Basic Care OmeprazoleOmeprazole
0113-0520good sense omeprazoleomeprazole
0113-0915Good Sense OmeprazoleOmeprazole
0113-1723Good Sense OmeprazoleOmeprazole
0113-1803good sense omeprazole delayed releaseomeprazole
0093-5294OmeprazoleOmeprazole
0363-0007omeprazoleOmeprazole
0363-0915omeprazoleOmeprazole
0363-1607OmeprazoleOmeprazole
0363-1819omeprazoleomeprazole
0378-5211Omeprazoleomeprazole
0378-5222Omeprazoleomeprazole
0378-6150Omeprazoleomeprazole
0615-1359OmeprazoleOmeprazole
0615-2302OmeprazoleOmeprazole
0615-2305OmeprazoleOmeprazole
0615-7933OmeprazoleOmeprazole
0615-8079OmeprazoleOmeprazole
0615-8320OmeprazoleOmeprazole
0615-8406OmeprazoleOmeprazole
0781-2234OmeprazoleOmeprazole
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