Home NDC 0113-7520-74 basic care omeprazole
Product NDC 0113-7520
Requested package NDC 0113-7520-74
11-digit product format 001137520
Labeler code 0113
Product ID 0113-7520_1abb9b6b-1b11-4fc9-beeb-3985edc5cf61
Type HUMAN OTC DRUG
Nonproprietary name omeprazole
Dosage form TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route ORAL
Labeler L. Perrigo Company
Application NDA209400
Marketing category NDA
Marketing start 2018-08-30
Marketing end 0000-00-00
Substance OMEPRAZOLE
Active strength 20 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209400-001 OMEPRAZOLE OMEPRAZOLE 20MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL RLD, RS 2017-07-05
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209400-001 10076494 2036-12-08 Drug product 2018-09-18 N209400-001 10835488 2036-12-08 Drug product 2020-11-23
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N209400-001 OMEPRAZOLE 20MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL RLD, RS 2017-07-05 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N209400-001 10076494 2036-12-08 Drug product 2018-09-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N209400-001 10835488 2036-12-08 Drug product 2020-11-23 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 18 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0113-7520-74 00113752074 14 BLISTER PACK in 1 CARTON (0113-7520-74) > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK 14 blister pack 2018-10-17 0000-00-00 No No Current