Home NDC 50594-011 Sound Body Omeprazole
Product NDC 50594-011
11-digit product format 505940011
Labeler code 50594
Product ID 50594-011_feaa1f7e-eb69-47c4-9db8-56a2f0850579
Type HUMAN OTC DRUG
Nonproprietary name Omeprazole
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Big Lots Stores, Inc.
Application NDA022032
Marketing category NDA
Marketing start 2015-08-17
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 N022032-001 OMEPRAZOLE OMEPRAZOLE 20MG TABLET, DELAYED RELEASE / ORAL RLD, RS 2007-12-04
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022032-001 12599565 2030-01-31 Drug product 2026-05-11
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 N022032-001 OMEPRAZOLE 20MG TABLET, DELAYED RELEASE / ORAL RLD, RS 2007-12-04 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 N022032-001 12599565 2030-01-31 Drug product 2026-05-11 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 3 · 58 matching rows.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OMEPRAZOLE ACTIVE INGREDIENT KG60484QX9 SOUND BODY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BIG LOTS STORES, INC.] 1 OMEPRAZOLE ACTIVE MOIETY KG60484QX9 SOUND BODY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BIG LOTS STORES, INC.] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ SOUND BODY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BIG LOTS STORES, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SOUND BODY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BIG LOTS STORES, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SOUND BODY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BIG LOTS STORES, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SOUND BODY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BIG LOTS STORES, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SOUND BODY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BIG LOTS STORES, INC.] 1 MONOETHANOLAMINE INACTIVE INGREDIENT 5KV86114PT SOUND BODY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BIG LOTS STORES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SOUND BODY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BIG LOTS STORES, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J SOUND BODY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BIG LOTS STORES, INC.] 1 SODIUM STEARATE INACTIVE INGREDIENT QU7E2XA9TG SOUND BODY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BIG LOTS STORES, INC.] 1 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI SOUND BODY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BIG LOTS STORES, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U SOUND BODY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BIG LOTS STORES, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SOUND BODY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BIG LOTS STORES, INC.] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM SOUND BODY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BIG LOTS STORES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50594-011 SOUND BODY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BIG LOTS STORES, INC.] 3 Legacy NDC 20190511_5e72b06d-5724-4c1b-8eb7-721cfd3f317b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50594-011-03 50594001103 3 BOTTLE in 1 CARTON (50594-011-03) > 14 TABLET, DELAYED RELEASE in 1 BOTTLE 3 bottle 2019-03-25 0000-00-00 No No Current 50594-011-74 50594001174 14 BLISTER PACK in 1 CARTON (50594-011-74) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK 14 blister pack 2015-08-17 0000-00-00 No No Current