NDC 71713-201

Omeprazole

Omeprazole

Omeprazole is a Oral Tablet, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Thirty Madison Inc. The primary component is Omeprazole.

Product ID71713-201_70eb534b-5e63-9e02-3730-b35daaeab17c
NDC71713-201
Product TypeHuman Otc Drug
Proprietary NameOmeprazole
Generic NameOmeprazole
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA207740
Labeler NameThirty Madison Inc
Substance NameOMEPRAZOLE
Active Ingredient Strength20 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71713-201-01

1 BOTTLE in 1 CARTON (71713-201-01) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date2019-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71713-201-03 [71713020103]

Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207740
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-31

NDC 71713-201-01 [71713020101]

Omeprazole TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA207740
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-31

Drug Details

Active Ingredients

IngredientStrength
OMEPRAZOLE20 mg/1

NDC Crossover Matching brand name "Omeprazole" or generic name "Omeprazole"

NDCBrand NameGeneric Name
0093-5294OmeprazoleOmeprazole
0363-0007omeprazoleOmeprazole
0363-0915omeprazoleOmeprazole
0363-1607OmeprazoleOmeprazole
0363-1819omeprazoleomeprazole
0363-9980OmeprazoleOMEPRAZOLE MAGNESIUM
0378-5211Omeprazoleomeprazole
0378-5222Omeprazoleomeprazole
0378-6150Omeprazoleomeprazole
0615-1359OmeprazoleOmeprazole
0615-2302OmeprazoleOmeprazole
0615-2305OmeprazoleOmeprazole
0615-7933OmeprazoleOmeprazole
0615-8079OmeprazoleOmeprazole
0615-8320OmeprazoleOmeprazole
0615-8406OmeprazoleOmeprazole
0781-2234OmeprazoleOmeprazole
68016-759OmeprazoleOmeprazole
68071-1522OmeprazoleOmeprazole
68071-2180OmeprazoleOmeprazole
68071-1948OmeprazoleOmeprazole
68071-3285OmeprazoleOmeprazole
68071-3007OmeprazoleOmeprazole
68071-2199OmeprazoleOmeprazole
68071-4051OmeprazoleOmeprazole
68071-3368OmeprazoleOmeprazole
68071-4140OmeprazoleOmeprazole
68071-4146OmeprazoleOmeprazole
68071-4024OmeprazoleOmeprazole
68071-4025OmeprazoleOmeprazole
68084-466OmeprazoleOmeprazole
68084-128OmeprazoleOmeprazole
68151-3088OmeprazoleOmeprazole
68382-411OmeprazoleOmeprazole
68382-412OmeprazoleOmeprazole
68382-500OmeprazoleOmeprazole
68462-395OmeprazoleOmeprazole
68462-396OmeprazoleOmeprazole
68462-397OmeprazoleOmeprazole
68788-6881OmeprazoleOmeprazole
68788-1554OmeprazoleOmeprazole
68788-9748OmeprazoleOmeprazole
68788-6995OmeprazoleOmeprazole
68788-9955OmeprazoleOmeprazole
69181-158OmeprazoleOmeprazole
69189-0147OmeprazoleOmeprazole
69677-180OmeprazoleOmeprazole
69618-047OmeprazoleOmeprazole
69842-791OmeprazoleOmeprazole
70518-0056OmeprazoleOmeprazole

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.