topcare omeprazole and sodium bicarbonate

Product NDC

36800-732

11-digit product format

368000732

Labeler code

36800

Product ID

36800-732_a6711c47-e0cf-4ef1-a16e-606e6522a10e

Type

HUMAN OTC DRUG

Nonproprietary name

Omeprazole, sodium bicarbonate

Dosage form

CAPSULE, GELATIN COATED

Route

ORAL

Labeler

Topco Associates LLC

Application

ANDA201361

Marketing category

ANDA

Marketing start

2017-03-13

Marketing end

0000-00-00

Substance

OMEPRAZOLE; SODIUM BICARBONATE

Active strength

20 mg/1; mg/1

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record