Pantoprazole Sodium

Product NDC
65862-559
Requested package NDC
65862-559-55
11-digit product format
658620559
Labeler code
65862
Product ID
65862-559_4784124c-9df4-42f6-8044-c0480c1a3bbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA202038
Marketing category
ANDA
Marketing start
2012-09-28
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage65862-55965862-559-55UNFINISHEDActive or certified unfinished drug listing2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-276db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-174184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-104bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-305b2001dcd8f5…54b53d4dc9e4…

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
A202038-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28
A202038-002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202038-001AB
A202038-002AB

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 UTC2026-02A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202038-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A202038-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2012-09-28782e0a99824c…

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 UTC2026-02A202038-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202038-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202038-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202038-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202038-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202038-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202038-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202038-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202038-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202038-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202038-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202038-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202038-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202038-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202038-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202038-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202038-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202038-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202038-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202038-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202038-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202038-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202038-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202038-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202038-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202038-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202038-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202038-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202038-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202038-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202038-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202038-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202038-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202038-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202038-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202038-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202038-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202038-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202038-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202038-002AB1782e0a99824c…

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
7418f358-f536-4de6-adf0-562b4373f2e3Available 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
65862-559-10Pantoprazole Sodium10 in 1 BLISTER PACKTABLET, DELAYED RELEASE1024
65862-559-10Pantoprazole Sodium10 in 1 CARTONTABLET, DELAYED RELEASE1024
65862-559-90Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9024
65862-559-99Pantoprazole Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE100024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-559-90EA - Each65862-55983395f2b-8057-4b28-9e21-e022588d032212013-06-04
65862-559-99EA - Each65862-559a4b3ea75-b090-4d0f-901d-e4ca41c0ffdf12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
HYDROXYPROPYL CELLULOSE (TYPE L)INACTIVE INGREDIENTUKE75GEA7FPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
MANNITOLINACTIVE INGREDIENT3OWL53L36APANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]5
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36APANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-559PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]22Current NDC, Legacy NDC, 4 package rows20240218_7418f358-f536-4de6-adf0-562b4373f2e3.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.76e1839b-7462-4344-b319-001a5f57d67a2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.f38a6df2-1dd4-48bf-9ec4-1113ce492e782026-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMUnit Dose Solutions, Inc.558dc7e1-dfd5-d3d7-e063-6394a90ab9c32026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMREMEDYREPACK INC.f313159c-115a-4cf6-b32e-9ddc833fd51c2026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMUnit Dose Solutions, Inc.5566b4b1-b4f5-4020-e063-6394a90a52572026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMHAWAII REPACK, INC.f403c94d-68b7-43df-8c8e-c9fef3309cfc2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack03dea010-4bae-43ab-893e-9bbddb58062d2026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMCoupler LLC5331f534-4724-52e8-e063-6394a90aa5482026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMCoupler LLC52bbab54-9f11-77bc-e063-6394a90ab4492026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack9a1159d3-b9fa-4026-962c-d3001002e6102026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMQPharma Inc0e200326-8885-18d0-e063-6294a90aad2f2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMAurobindo Pharma Limited7418f358-f536-4de6-adf0-562b4373f2e32026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
ndc (product): 65862-559
Pantoprazole SodiumPANTOPRAZOLE SODIUMNorthStar Rx LLC6637d90b-b268-4a5f-ab5b-885f2d5f0d4b2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMBurel Pharmaceuticals, LLC3cc5197e-6b39-4415-b963-d4bbeecd79532026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLC6229247e-ee15-466e-a8ac-adcd646b738d2026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMMajor Pharmaceuticalsde419aa0-caa9-40fb-bc6d-e341c94273c72026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMNorthwind Health Company, LLCf2a1af50-a051-3e55-e053-2a95a90a91842026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMNorthwind Health Company, LLCd9deb251-96d3-5f96-e053-2a95a90a07922026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMNuCare Pharmaceuticals,Inc.8aac1642-6cb0-6ad2-e053-2a95a90a4cbd2025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038
Pantoprazole SodiumPANTOPRAZOLE SODIUMQuality Care Products, LLCa9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e22024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202038
application number: ANDA202038

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN03dea010-4bae-43ab-893e-9bbddb58062d102
251872pantoprazole 20 MG Delayed Release Oral TabletSCD03dea010-4bae-43ab-893e-9bbddb58062d102
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY03dea010-4bae-43ab-893e-9bbddb58062d102
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN7418f358-f536-4de6-adf0-562b4373f2e324
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN7418f358-f536-4de6-adf0-562b4373f2e324
251872pantoprazole 20 MG Delayed Release Oral TabletSCD7418f358-f536-4de6-adf0-562b4373f2e324
314200pantoprazole 40 MG Delayed Release Oral TabletSCD7418f358-f536-4de6-adf0-562b4373f2e324
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY7418f358-f536-4de6-adf0-562b4373f2e324
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY7418f358-f536-4de6-adf0-562b4373f2e324
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN76e1839b-7462-4344-b319-001a5f57d67a20
251872pantoprazole 20 MG Delayed Release Oral TabletSCD76e1839b-7462-4344-b319-001a5f57d67a20
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY76e1839b-7462-4344-b319-001a5f57d67a20
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN517d6b02-0e68-4d6b-98b3-eac0be457e6b9
251872pantoprazole 20 MG Delayed Release Oral TabletSCD517d6b02-0e68-4d6b-98b3-eac0be457e6b9
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY517d6b02-0e68-4d6b-98b3-eac0be457e6b9
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN1680b4ed-d5b0-4fd9-b1d1-04df6a2138be8
251872pantoprazole 20 MG Delayed Release Oral TabletSCD1680b4ed-d5b0-4fd9-b1d1-04df6a2138be8
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY1680b4ed-d5b0-4fd9-b1d1-04df6a2138be8
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNde419aa0-caa9-40fb-bc6d-e341c94273c76
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNde419aa0-caa9-40fb-bc6d-e341c94273c76
251872pantoprazole 20 MG Delayed Release Oral TabletSCDde419aa0-caa9-40fb-bc6d-e341c94273c76
314200pantoprazole 40 MG Delayed Release Oral TabletSCDde419aa0-caa9-40fb-bc6d-e341c94273c76
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYde419aa0-caa9-40fb-bc6d-e341c94273c76
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYde419aa0-caa9-40fb-bc6d-e341c94273c76
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNf2a1af50-a051-3e55-e053-2a95a90a91844
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN924a80b9-de48-90c0-e053-2995a90a00e14
251872pantoprazole 20 MG Delayed Release Oral TabletSCDf2a1af50-a051-3e55-e053-2a95a90a91844
251872pantoprazole 20 MG Delayed Release Oral TabletSCD924a80b9-de48-90c0-e053-2995a90a00e14
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYf2a1af50-a051-3e55-e053-2a95a90a91844
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY924a80b9-de48-90c0-e053-2995a90a00e14
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNa9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e23
251872pantoprazole 20 MG Delayed Release Oral TabletSCDa9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e23
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYa9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e23
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452
251872pantoprazole 20 MG Delayed Release Oral TabletSCD5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452
314200pantoprazole 40 MG Delayed Release Oral TabletSCD5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY5ff3cf6c-6f0a-4374-8b80-4e1eb1df62452
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN138b30cb-6b28-450e-9e7a-42576cc765451
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN1c46140c-2399-5ca3-e063-6394a90af33b1
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNf92276a1-b286-489d-a372-f441e49cfd631
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN138b30cb-6b28-450e-9e7a-42576cc765451
251872pantoprazole 20 MG Delayed Release Oral TabletSCD138b30cb-6b28-450e-9e7a-42576cc765451
251872pantoprazole 20 MG Delayed Release Oral TabletSCDf92276a1-b286-489d-a372-f441e49cfd631
251872pantoprazole 20 MG Delayed Release Oral TabletSCD1c46140c-2399-5ca3-e063-6394a90af33b1
314200pantoprazole 40 MG Delayed Release Oral TabletSCD138b30cb-6b28-450e-9e7a-42576cc765451
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY138b30cb-6b28-450e-9e7a-42576cc765451
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY1c46140c-2399-5ca3-e063-6394a90af33b1
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYf92276a1-b286-489d-a372-f441e49cfd631
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY138b30cb-6b28-450e-9e7a-42576cc765451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startStatus
65862-559-556586205595515000 TABLET, DELAYED RELEASE in 1 BAG (65862-559-55)28-SEP-12Current