Pantoprazole

Product NDC
68788-8505
11-digit product format
687888505
Labeler code
68788
Product ID
68788-8505_3b11bd25-3420-4257-b821-d3fc79ef7fc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077619
Marketing category
ANDA
Marketing start
2023-08-15
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
A077619-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19
A077619-002PANTOPRAZOLE 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
A077619-001AB
A077619-002AB

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 06:07:402026-07A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19caaa826d4ba7…
2026-08-18 06:07:402026-07A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077619-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077619-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19bb7c543d1eb4…

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 06:07:402026-07A077619-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077619-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077619-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077619-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077619-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077619-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077619-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077619-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077619-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077619-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077619-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077619-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077619-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077619-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077619-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077619-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077619-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077619-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077619-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077619-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077619-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077619-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077619-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077619-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077619-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077619-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077619-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077619-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077619-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077619-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077619-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077619-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077619-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077619-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077619-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077619-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077619-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077619-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077619-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077619-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole
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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb1e79ad-ff52-4696-8743-523f793b29d3Available 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
68788-8505-1Pantoprazole100 in 1 BOTTLETABLET, DELAYED RELEASE1003
68788-8505-3Pantoprazole30 in 1 BOTTLETABLET, DELAYED RELEASE303
68788-8505-6Pantoprazole60 in 1 BOTTLETABLET, DELAYED RELEASE603
68788-8505-8Pantoprazole120 in 1 BOTTLETABLET, DELAYED RELEASE1203
68788-8505-9Pantoprazole90 in 1 BOTTLETABLET, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8505-1EA - Each68788-850542d01955-cca6-4c59-9693-719e26f9b28f12023-10-16
68788-8505-3EA - Each68788-850546f4a115-b006-4899-a664-b99a5b5c717212023-10-16
68788-8505-6EA - Each68788-85050f7b14df-bd89-4630-b6b9-ce32609d7c8912023-10-16
68788-8505-8EA - Each68788-85056fe962e8-6c61-45cf-9837-cdff0a4170ee12023-10-16
68788-8505-9EA - Each68788-85054de8d04a-ab91-48ea-9777-2b34b3620bc812023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8505PANTOPRAZOLE TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 5 package rows20240727_bb1e79ad-ff52-4696-8743-523f793b29d3.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
PantoprazolePANTOPRAZOLEPreferred Pharmaceuticals Inc.bb1e79ad-ff52-4696-8743-523f793b29d32026-08-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077619
application number: ANDA077619
ndc (product): 68788-8505
PantoprazolePANTOPRAZOLECoupler LLC549da3e8-f223-2ee7-e063-6394a90a25d82026-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077619
application number: ANDA077619
PantoprazolePANTOPRAZOLESt. Mary's Medical Park Pharmacyed264262-21bb-1bae-e053-2995a90a8a5e2026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077619
application number: ANDA077619
PantoprazolePANTOPRAZOLENuCare Pharmaceuticals,Inc.51033ddc-a11a-80fa-e063-6394a90ac54c2026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077619
application number: ANDA077619
PantoprazolePANTOPRAZOLEPHOENIX RX LLC43fc6326-cfe6-7d1c-e063-6394a90abc242025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077619
application number: ANDA077619
PantoprazolePANTOPRAZOLEAdvanced Rx of Tennessee, LLC4136d983-75fa-9604-e063-6294a90aaac62025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077619
application number: ANDA077619
PantoprazolePANTOPRAZOLENuCare Pharmaceuticals,Inc.07ff83f9-7039-ac26-e063-6394a90a37ce2025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077619
application number: ANDA077619
PantoprazolePANTOPRAZOLENuCare Pharmaceuticals, Inc.2bed1bae-519f-1bb9-e063-6294a90a795b2025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077619
application number: ANDA077619
PantoprazolePANTOPRAZOLENorthStar RxLLC82f0103a-2b97-d210-6d7d-c627d60ad6942023-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077619
application number: ANDA077619
PantoprazolePANTOPRAZOLEDr.Reddy's Laboratories Limited564709e8-358f-c185-4ecb-b3849c3fe59c2023-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077619
application number: ANDA077619

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNbb1e79ad-ff52-4696-8743-523f793b29d33
251872pantoprazole 20 MG Delayed Release Oral TabletSCDbb1e79ad-ff52-4696-8743-523f793b29d33
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYbb1e79ad-ff52-4696-8743-523f793b29d33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8505-168788850501100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8505-1) 2023-08-15NoNoCurrent
68788-8505-36878885050330 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8505-3) 2023-08-15NoNoCurrent
68788-8505-66878885050660 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8505-6) 2023-08-15NoNoCurrent
68788-8505-868788850508120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8505-8) 2023-08-15NoNoCurrent
68788-8505-96878885050990 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8505-9) 2023-08-15NoNoCurrent