Pantoprazole Sodium

Product NDC
55154-4382
11-digit product format
551544382
Labeler code
55154
Product ID
55154-4382_44992b52-7e49-4f7d-878c-ff9ce5c24c66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pantoprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA090970
Marketing category
ANDA
Marketing start
2011-02-23
Substance
PANTOPRAZOLE SODIUM
Active strength
40 mg/1
Pharmacologic classes
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 1.

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
A090970-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19
A090970-002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090970-001AB
A090970-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090970-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090970-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090970-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090970-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090970-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090970-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090970-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090970-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090970-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090970-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090970-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090970-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090970-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090970-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090970-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090970-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090970-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090970-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090970-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090970-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090970-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090970-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090970-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090970-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090970-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090970-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090970-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090970-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090970-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090970-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090970-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090970-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090970-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090970-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090970-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090970-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090970-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090970-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090970-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090970-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANTOPRAZOLE SODIUM40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6871619Q5XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
314200Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e17e4a72-d6a4-4a83-a921-88af9ef028a6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ae9ebba7-ac9e-4a6e-90ef-4bd9760ec041Product name820260304
41d62193-73fc-49cf-9907-add9588e2da1Product name920260112
f12d0d0d-c068-46c6-872c-96c9d38533bbProduct name120250116
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-4382-0Pantoprazole Sodium1 in 1 BLISTER PACKTABLET, DELAYED RELEASE114
55154-4382-0Pantoprazole Sodium10 in 1 BAGTABLET, DELAYED RELEASE1014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
MANNITOLINACTIVE INGREDIENT3OWL53L36APANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4382PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH 107, LLC]12Current NDC, Legacy NDC, 2 package rows20241010_e17e4a72-d6a4-4a83-a921-88af9ef028a6.zip

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMSafecor Health LLC5e1cbf26-d379-4315-8732-3939968f32c02026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLCe17e4a72-d6a4-4a83-a921-88af9ef028a62026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
ndc (product): 55154-4382
Pantoprazole SodiumPANTOPRAZOLE SODIUMQPharma Incfbd035d0-529c-6033-e053-6294a90abf072025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole SodiumPANTOPRAZOLE SODIUMMylan Institutional Inc.a9b0d279-118b-4372-bd51-d4bad9c1cfca2025-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCd27e1fdd-e23f-0d60-e053-2a95a90a90872024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole SodiumPANTOPRAZOLE SODIUMNCS HealthCare of KY, LLC dba Vangard Labs6faf465b-c3a3-4ae7-9e16-1ba758f6962a2024-09-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack7d51104d-b135-421f-8425-03b5772e71032024-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole SodiumPANTOPRAZOLE SODIUMMylan Pharmaceuticals Inc.56ad5b97-8e5f-48a5-b2ba-a5484b43d0182023-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNe17e4a72-d6a4-4a83-a921-88af9ef028a614
314200pantoprazole 40 MG Delayed Release Oral TabletSCDe17e4a72-d6a4-4a83-a921-88af9ef028a614
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYe17e4a72-d6a4-4a83-a921-88af9ef028a614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4382-05515443820010 BLISTER PACK in 1 BAG (55154-4382-0) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK10 blister pack2011-02-230000-00-00NoNoCurrent