GoodMeds 24HR Acid Reducer Omeprazole 20mg

Product NDC
82725-4052
Requested package NDC
82725-4052-1
11-digit product format
827254052
Labeler code
82725
Product ID
82725-4052_58c9c8ef-b92a-14eb-e063-6294a90a3761
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole 20mg
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Cabinet Health P.B.C.
Application
ANDA211732
Marketing category
ANDA
Marketing start
2026-08-17
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211732-001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-2584e616aacf4f…
2026-08-18 06:07:402026-07A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-254b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211732-001OMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-03-25a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
GoodMeds 24HR Acid Reducer Omeprazole 20mg
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KG60484QX9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
402014Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
58c9c8ef-b929-14eb-e063-6294a90a3761Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GoodMeds 24HR Acid Reducer Omeprazole 20mgOMEPRAZOLE 20MGCabinet Health P.B.C.58c9c8ef-b929-14eb-e063-6294a90a37612026-08-11WarningsExact identifier
application applno (ANDA): 211732
application number: ANDA211732
ndc (package): 82725-4052-1
ndc (product): 82725-4052
ndc11 (package): 82725405201
OmeprazoleOMEPRAZOLEAllegiant Health3344c589-c4ac-4f2d-8d32-828db4e825a62025-03-19WarningsExact identifier
application applno (ANDA): 211732
application number: ANDA211732
OmeprazoleOMEPRAZOLECHAIN DRUG MARKETING ASSOCIATION, INC.da09aac6-8fce-448b-98ba-1fc9bce420752024-04-17WarningsExact identifier
application applno (ANDA): 211732
application number: ANDA211732
OmeprazoleOMEPRAZOLEA-S Medication Solutionsa52842ac-ac9d-4344-9823-b8b2afb079032023-12-14WarningsExact identifier
application applno (ANDA): 211732
application number: ANDA211732
OmeprazoleOMEPRAZOLECamber Consumer Care Inc9c856d3a-e38f-4006-a43a-ec1a9fa0f0572022-11-28WarningsExact identifier
application applno (ANDA): 211732
application number: ANDA211732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82725-4052-1827254052013 BOTTLE in 1 CARTON (82725-4052-1) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2026-08-17NoNoCurrent