FDA.reportPublic FDA data

OMEPRAZOLE AND SODIUM BICARBONATE CAPSULES

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-12-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 20:47:15

Label at a glance#

Productomeprazole and sodium bicarbonate
Active ingredientOMEPRAZOLE, SODIUM BICARBONATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1101-3 in bottle of 30 capsules

 

Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg

 

Rx only

 

30 capsules

 

ZYDUS

Omeprazole capsules
Omeprazole capsules

NDC 70771-1102-3 in bottle of 30 capsules

 

Omeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg

 

Rx only

 

30 capsules

 

ZYDUS

omeprazole capsules02
omeprazole capsules02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-110170771-1101-7, 70771-1101-3, 70771-1101-9, 70771-1101-1, 70771-1101-5, 70771-1101-0, 70771-1101-2, 70771-1101-4
70771-110270771-1102-3, 70771-1102-9, 70771-1102-1, 70771-1102-5, 70771-1102-0, 70771-1102-2, 70771-1102-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
OMEPRAZOLEKG60484QX9ACTIB
SODIUM BICARBONATE8MDF5V39QOACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
GELATIN2G86QN327LIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
BUTYL ALCOHOL8PJ61P6TS3IACT
ALCOHOL3K9958V90MIACT
ISOPROPYL ALCOHOLND2M416302IACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SHELLAC46N107B71OIACT
AMMONIA5138Q19F1XIACT
OMEPRAZOLEKG60484QX9ACTIB
SODIUM BICARBONATE8MDF5V39QOACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
GELATIN2G86QN327LIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
BUTYL ALCOHOL8PJ61P6TS3IACT
ALCOHOL3K9958V90MIACT
ISOPROPYL ALCOHOLND2M416302IACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SHELLAC46N107B71OIACT
AMMONIA5138Q19F1XIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203290-001OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-25
A203290-002OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203290-001AB
A203290-002AB

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-2584e616aacf4f…
2026-09-14 22:38:342026-08A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-2584e616aacf4f…
2026-08-18 06:07:402026-07A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203290-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALAB2018-05-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203290-002OMEPRAZOLE AND SODIUM BICARBONATE40MG;1.1GMCAPSULE / ORALAB2018-05-2574a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203290-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203290-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A203290-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203290-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203290-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203290-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203290-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203290-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203290-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203290-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203290-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203290-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203290-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203290-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203290-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203290-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203290-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203290-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203290-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203290-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203290-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203290-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203290-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203290-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203290-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203290-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203290-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203290-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203290-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203290-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203290-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203290-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203290-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203290-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203290-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203290-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203290-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203290-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203290-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203290-002AB174a2ff9319b5…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1b6c0133-3a67-449f-85ae-f1eb8ebf23d22fdb0934-5bf4-47c6-8368-2dbaaabd4b8d2025-04-29Exact identifier
spl set id: 2fdb0934-5bf4-47c6-8368-2dbaaabd4b8d

Reported adverse events (FAERS/openFDA)#

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