Application 076048

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL10MGNoNo
002OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL20MGNoNo
003OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL40MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076048-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22
A076048-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22
A076048-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A076048-001AB
A076048-002AB
A076048-003AB

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-228072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076048-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076048-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076048-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076048-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076048-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076048-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076048-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076048-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076048-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076048-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076048-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076048-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076048-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076048-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076048-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076048-001AB18072bd15b7f6…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEBryant Ranch Prepack1249c42d-6358-48b3-8fe0-10333c7f501d2024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048
OmeprazoleOMEPRAZOLEBryant Ranch Prepack44349466-73ea-4053-8ff6-5b4b7372c9cd2024-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048
OmeprazoleOMEPRAZOLEProficient Rx LP03ac077f-3873-4087-96d0-89049161dea92024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048
ndc (product): 63187-070
ndc (product): 63187-061
OmeprazoleOMEPRAZOLEProficient Rx LP253451a6-02a9-4b27-aed7-f3dbc2e096822024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048
OmeprazoleOMEPRAZOLEApotex Corpb83329ac-a65e-b3af-a3fb-c5a6c740e5e72024-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048
ndc (product): 60505-0065
ndc (product): 60505-0146
ndc (product): 60505-0145
ndc (product): 60505-3952
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLCa0dc4ffa-db18-4871-9d36-51d02e3b2bd92019-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 100 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-5684OmeprazoleOmeprazoleMajor PharmaceuticalsANDACurrent
0904-5684OmeprazoleOmeprazoleMajor PharmaceuticalsANDACurrent
10544-878OmeprazoleOmeprazoleBlenheim Pharmacal, Inc.ANDACurrent
10544-895OmeprazoleOmeprazoleBlenheim Pharmacal, Inc.ANDACurrent
10544-898OmeprazoleOmeprazoleBlenheim Pharmacal, Inc.ANDACurrent
33358-273OmeprazoleOmeprazoleRxChange Co.ANDACurrent
42291-572OmeprazoleOmeprazoleAvKARE, Inc.ANDACurrent
42291-572OmeprazoleOmeprazoleAvKAREANDACurrent
42291-573OmeprazoleOmeprazoleAvKARE, Inc.ANDACurrent
42291-573OmeprazoleOmeprazoleAvKAREANDACurrent
42708-080OmeprazoleOmeprazoleQPharma IncANDACurrent
42708-080OmeprazoleOmeprazoleQPharma IncANDACurrent
42708-080OmeprazoleOmeprazoleQPharma IncANDACurrent
43063-212OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-212OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-212OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-451OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-451OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-451OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
48433-327OmeprazoleOmeprazoleSafecor Health, LLCANDACurrent
50436-0065OmeprazoleOmeprazoleUnit Dose ServicesANDACurrent
50436-0146OmeprazoleOmeprazoleUnit Dose ServicesANDACurrent
50436-3127OmeprazoleOmeprazoleUnit Dose ServicesANDACurrent
51655-022OMEPRAZOLEOMEPRAZOLE DRNorthwind Pharmaceuticals, LLCANDACurrent
51655-023OMEPRAZOLEOMEPRAZOLENorthwind Pharmaceuticals, LLCANDACurrent
53808-0745Omeprazole Delayed-ReleaseOMEPRAZOLEDOH CENTRAL PHARMACYANDACurrent
55154-3348OmeprazoleOmeprazoleCardinal HealthANDACurrent
55154-3348OmeprazoleOmeprazoleCardinal HealthANDACurrent
58517-020OmeprazoleOmeprazoleNew Horizon Rx Group, LLCANDACurrent
60429-182OmeprazoleOmeprazoleGolden State Medical Supply, Inc.ANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60760-521OmeprazoleOmeprazoleSt. Mary's Medical Park PharmacyANDACurrent
61919-176OMEPRAZOLE DROMEPRAZOLE DRDirect RxANDACurrent
61919-176OMEPRAZOLE DROMEPRAZOLE DRDirect RxANDACurrent
61919-176OMEPRAZOLE DROMEPRAZOLE DRDirect RxANDACurrent
61919-176OMEPRAZOLE DROMEPRAZOLE DRDirect RxANDACurrent
61919-773OMEPRAZOLE DROMEPRAZOLE DRDirect RxANDACurrent
61919-773OMEPRAZOLE DROMEPRAZOLE DRDirect RxANDACurrent
61919-773OMEPRAZOLE DROMEPRAZOLE DRDirect RxANDACurrent
61919-773OMEPRAZOLE DROMEPRAZOLE DRDirect RxANDACurrent
63187-061OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-061OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-061OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-070OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-070OmeprazoleOmeprazoleProficient Rx LPANDACurrent