Pantoprazole Sodium

Product NDC
63187-938
11-digit product format
631870938
Labeler code
63187
Product ID
63187-938_96e2029a-2614-4862-b7de-dbbdbf10006b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078281
Marketing category
ANDA
Marketing start
2011-01-20
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078281-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20
A078281-002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078281-001AB
A078281-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20caaa826d4ba7…
2026-08-18 06:07:402026-07A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078281-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078281-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078281-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078281-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078281-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078281-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078281-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078281-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078281-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078281-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078281-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078281-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078281-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078281-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078281-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078281-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078281-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078281-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078281-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078281-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078281-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078281-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078281-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078281-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078281-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078281-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078281-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078281-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078281-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078281-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078281-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078281-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078281-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078281-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078281-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078281-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078281-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078281-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078281-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078281-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole Sodium
Listing expiration
2026-12-31

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
a03aa46f-9eb5-4cf4-addf-745d94af8261Available 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
63187-938-30Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE305
63187-938-60Pantoprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE605
63187-938-90Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-938-30EA - Each63187-93862e6f8cd-b7f4-47ed-8f8a-3c17614e91a012018-02-20
63187-938-90EA - Each63187-938110f5887-c21b-4883-b93a-996d6ae4e26012023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-938PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20220702_a03aa46f-9eb5-4cf4-addf-745d94af8261.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMAvPAKdcac4022-fea1-67c5-3331-fefcc3c440d82026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLC410d5577-e50a-44f3-aaa8-fbf391a0c2612025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMChartwell RX, LLC42a969c3-1144-4151-9cf3-3e9bace6a3802025-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMAvPAKb9fa8381-b75e-b1cd-e053-2a95a90a98832025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMPD-Rx Pharmaceuticals, Inc.b422c5eb-9a6d-4f8c-863d-ca515ec780c22025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMAphena Pharma Solutions - Tennessee, LLCc9bc288b-e84c-4e31-a769-c87a592260862025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack3e5421ef-0875-4a04-b17d-95cca0052c832024-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMGolden State Medical Supply, Inc.d6aae78e-308b-7072-e053-2a95a90aaa102024-03-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMLannett Company, Inc.e7705bf6-e473-4b9c-bb5d-57e26ffe7b972023-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
Pantoprazole SodiumPANTOPRAZOLE SODIUMProficient Rx LPa03aa46f-9eb5-4cf4-addf-745d94af82612022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281
ndc (product): 63187-938

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNa03aa46f-9eb5-4cf4-addf-745d94af82615
314200pantoprazole 40 MG Delayed Release Oral TabletSCDa03aa46f-9eb5-4cf4-addf-745d94af82615
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYa03aa46f-9eb5-4cf4-addf-745d94af82615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-938-306318709383030 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-938-30) 2017-12-010000-00-00NoNoCurrent
63187-938-606318709386060 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-938-60) 2017-12-010000-00-00NoNoCurrent
63187-938-906318709389090 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-938-90) 2017-12-010000-00-00NoNoCurrent