Pantoprazole Sodium

Product NDC
65162-636
11-digit product format
651620636
Labeler code
65162
Product ID
65162-636_774b587f-7d77-4d2e-97f6-2b19d8cec56a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA205119
Marketing category
ANDA
Marketing start
2016-06-20
Substance
PANTOPRAZOLE SODIUM
Active strength
20 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
A205119-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26
A205119-002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205119-001AB
A205119-002AB

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 06:07:402026-07A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26caaa826d4ba7…
2026-08-18 06:07:402026-07A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205119-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205119-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2016-01-26bb7c543d1eb4…

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 06:07:402026-07A205119-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205119-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205119-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205119-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205119-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205119-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205119-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205119-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205119-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205119-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205119-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205119-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205119-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205119-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205119-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205119-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205119-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205119-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205119-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205119-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205119-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205119-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205119-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205119-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205119-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205119-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205119-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205119-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205119-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205119-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205119-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205119-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205119-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205119-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205119-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205119-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205119-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205119-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205119-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205119-002AB1bb7c543d1eb4…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANTOPRAZOLE SODIUM20 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
251872Internal RxNorm lookup
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
f3ded82a-cf0d-4844-944a-75f9f9215ff0Available 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-636-03Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3018
65162-636-09Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-636-09EA - Each65162-636716a7184-3879-4088-b670-6f1718b1e28812016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-636PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS LLC]18Current NDC, Legacy NDC, 2 package rows20250124_f3ded82a-cf0d-4844-944a-75f9f9215ff0.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLEAmneal Pharmaceuticals LLCf3ded82a-cf0d-4844-944a-75f9f9215ff02026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205119
application number: ANDA205119
ndc (product): 65162-636
Pantoprazole SodiumPANTOPRAZOLEPHOENIX RX LLC440b9ae8-2fb8-5d35-e063-6294a90a82b62025-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205119
application number: ANDA205119
Pantoprazole SodiumPANTOPRAZOLEBryant Ranch Prepackd212e8ec-f7ff-4727-a83e-0edc4ca7e6d12025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205119
application number: ANDA205119
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx of Tennessee, LLCb3277cb8-26d0-bce0-e053-2a95a90af6dd2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205119
application number: ANDA205119
Pantoprazole SodiumPANTOPRAZOLEProficient Rx LPa7dc4321-331d-49af-976c-cfd69d0055d92022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205119
application number: ANDA205119
Pantoprazole SodiumPANTOPRAZOLEProficient Rx LP6d03491f-20c6-4878-9741-2e21e221eff22019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205119
application number: ANDA205119

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNf3ded82a-cf0d-4844-944a-75f9f9215ff018
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNf3ded82a-cf0d-4844-944a-75f9f9215ff018
251872pantoprazole 20 MG Delayed Release Oral TabletSCDf3ded82a-cf0d-4844-944a-75f9f9215ff018
314200pantoprazole 40 MG Delayed Release Oral TabletSCDf3ded82a-cf0d-4844-944a-75f9f9215ff018
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYf3ded82a-cf0d-4844-944a-75f9f9215ff018
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYf3ded82a-cf0d-4844-944a-75f9f9215ff018
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNd212e8ec-f7ff-4727-a83e-0edc4ca7e6d112
251872pantoprazole 20 MG Delayed Release Oral TabletSCDd212e8ec-f7ff-4727-a83e-0edc4ca7e6d112
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYd212e8ec-f7ff-4727-a83e-0edc4ca7e6d112
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNa7dc4321-331d-49af-976c-cfd69d0055d97
251872pantoprazole 20 MG Delayed Release Oral TabletSCDa7dc4321-331d-49af-976c-cfd69d0055d97
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYa7dc4321-331d-49af-976c-cfd69d0055d97
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNb3277cb8-26d0-bce0-e053-2a95a90af6dd6
251872pantoprazole 20 MG Delayed Release Oral TabletSCDb3277cb8-26d0-bce0-e053-2a95a90af6dd6
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYb3277cb8-26d0-bce0-e053-2a95a90af6dd6
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN440b9ae8-2fb8-5d35-e063-6294a90a82b61
251872pantoprazole 20 MG Delayed Release Oral TabletSCD440b9ae8-2fb8-5d35-e063-6294a90a82b61
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY440b9ae8-2fb8-5d35-e063-6294a90a82b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-636-036516206360330 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-636-03) 2016-06-200000-00-00NoNoCurrent
65162-636-096516206360990 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-636-09) 2016-06-200000-00-00NoNoCurrent