Pantoprazole Sodium

Product NDC
62175-617
11-digit product format
621750617
Labeler code
62175
Product ID
62175-617_cfbf12d8-f656-4b99-bd2e-fb11bab669e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
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 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
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 · 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 UTC2026-02A078281-001PANTOPRAZOLE 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…
2021-12-28 21:50 UTC2021-12A078281-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A078281-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-20782e0a99824c…

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 UTC2026-02A078281-001AB1011fe1cb6892…
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…
2021-12-28 21:50 UTC2021-12A078281-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078281-002AB1782e0a99824c…

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 · 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
e7705bf6-e473-4b9c-bb5d-57e26ffe7b97Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62175-617-43Pantoprazole Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE100057
62175-617-46Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9057

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62175-617-43EA - Each62175-61726d846a6-10cf-4ffd-afcf-c40057678ed512015-01-05
62175-617-46EA - Each62175-61761350bea-cc35-472b-a68a-77cc7f50653d12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
TALCINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]25
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
crospovidoneINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
glyceryl dibehenateINACTIVE INGREDIENTR8WTH25YS2PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
hypromellosesINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
isopropyl alcoholINACTIVE INGREDIENTND2M416302PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
talcINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]5
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [LEGACY PHARMACEUTICAL PACKAGING, LLC]3
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]3
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [LEGACY PHARMACEUTICAL PACKAGING, LLC]3
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]3
crospovidoneINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]3
CROSPOVIDONE (15 MPA.S AT 5%)INACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [LEGACY PHARMACEUTICAL PACKAGING, LLC]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [LEGACY PHARMACEUTICAL PACKAGING, LLC]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]3
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [LEGACY PHARMACEUTICAL PACKAGING, LLC]3
glyceryl dibehenateINACTIVE INGREDIENTR8WTH25YS2PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [LEGACY PHARMACEUTICAL PACKAGING, LLC]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]3
isopropyl alcoholINACTIVE INGREDIENTND2M416302PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [LEGACY PHARMACEUTICAL PACKAGING, LLC]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]3
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [LEGACY PHARMACEUTICAL PACKAGING, LLC]3
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]3
TALCINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [LEGACY PHARMACEUTICAL PACKAGING, LLC]3
talcINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [LEGACY PHARMACEUTICAL PACKAGING, LLC]3
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [LEGACY PHARMACEUTICAL PACKAGING, LLC]3
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
crospovidoneINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
glyceryl dibehenateINACTIVE INGREDIENTR8WTH25YS2PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
isopropyl alcoholINACTIVE INGREDIENTND2M416302PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
talcINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62175-617PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [LANNETT COMPANY, INC.]57Current NDC, Legacy NDC, 2 package rows20230819_e7705bf6-e473-4b9c-bb5d-57e26ffe7b97.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
ndc (product): 62175-617
Pantoprazole SodiumPANTOPRAZOLE SODIUMProficient Rx LPa03aa46f-9eb5-4cf4-addf-745d94af82612022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078281
application number: ANDA078281

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN3e5421ef-0875-4a04-b17d-95cca0052c83101
314200pantoprazole 40 MG Delayed Release Oral TabletSCD3e5421ef-0875-4a04-b17d-95cca0052c83101
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY3e5421ef-0875-4a04-b17d-95cca0052c83101
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
251872pantoprazole 20 MG Delayed Release Oral TabletSCDe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
314200pantoprazole 40 MG Delayed Release Oral TabletSCDe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYe7705bf6-e473-4b9c-bb5d-57e26ffe7b9757
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNb422c5eb-9a6d-4f8c-863d-ca515ec780c253
314200pantoprazole 40 MG Delayed Release Oral TabletSCDb422c5eb-9a6d-4f8c-863d-ca515ec780c253
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYb422c5eb-9a6d-4f8c-863d-ca515ec780c253
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNdcac4022-fea1-67c5-3331-fefcc3c440d813
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNdcac4022-fea1-67c5-3331-fefcc3c440d813
251872pantoprazole 20 MG Delayed Release Oral TabletSCDdcac4022-fea1-67c5-3331-fefcc3c440d813
314200pantoprazole 40 MG Delayed Release Oral TabletSCDdcac4022-fea1-67c5-3331-fefcc3c440d813
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYdcac4022-fea1-67c5-3331-fefcc3c440d813
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYdcac4022-fea1-67c5-3331-fefcc3c440d813
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNee7f6011-09dc-405d-8fd7-cd48e8bfa71a5
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 Delayed Release Oral TabletSCDee7f6011-09dc-405d-8fd7-cd48e8bfa71a5
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYa03aa46f-9eb5-4cf4-addf-745d94af82615
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYee7f6011-09dc-405d-8fd7-cd48e8bfa71a5
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNd6aae78e-308b-7072-e053-2a95a90aaa104
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNd6aae78e-308b-7072-e053-2a95a90aaa104
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN5205ff55-e7aa-01ac-e054-00144ff8d46c4
251872pantoprazole 20 MG Delayed Release Oral TabletSCDd6aae78e-308b-7072-e053-2a95a90aaa104
314200pantoprazole 40 MG Delayed Release Oral TabletSCDd6aae78e-308b-7072-e053-2a95a90aaa104
314200pantoprazole 40 MG Delayed Release Oral TabletSCD5205ff55-e7aa-01ac-e054-00144ff8d46c4
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYd6aae78e-308b-7072-e053-2a95a90aaa104
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYd6aae78e-308b-7072-e053-2a95a90aaa104
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY5205ff55-e7aa-01ac-e054-00144ff8d46c4
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSNc9bc288b-e84c-4e31-a769-c87a592260863
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNc9bc288b-e84c-4e31-a769-c87a592260863
251872pantoprazole 20 MG Delayed Release Oral TabletSCDc9bc288b-e84c-4e31-a769-c87a592260863
314200pantoprazole 40 MG Delayed Release Oral TabletSCDc9bc288b-e84c-4e31-a769-c87a592260863
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSYc9bc288b-e84c-4e31-a769-c87a592260863
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYc9bc288b-e84c-4e31-a769-c87a592260863
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN09d22c7f-c293-9800-e063-6294a90a5fb72
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN7ea32160-ed8d-9e16-e053-2991aa0a51122
314200pantoprazole 40 MG Delayed Release Oral TabletSCD09d22c7f-c293-9800-e063-6294a90a5fb72
314200pantoprazole 40 MG Delayed Release Oral TabletSCD7ea32160-ed8d-9e16-e053-2991aa0a51122
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY09d22c7f-c293-9800-e063-6294a90a5fb72
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY7ea32160-ed8d-9e16-e053-2991aa0a51122
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNbb8add3c-11ed-7096-e053-2995a90a323c1
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN3d081e89-cc4b-411d-8f2a-5ba345e35a371
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN61cf498c-d6b8-5e26-e053-2991aa0a59c71
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN7d77134c-2082-39e8-e053-2991aa0a4a3b1
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSN95640d00-4047-43cd-b1d7-8aa34fc974cd1
314200pantoprazole 40 MG Delayed Release Oral TabletSCD7d77134c-2082-39e8-e053-2991aa0a4a3b1
314200pantoprazole 40 MG Delayed Release Oral TabletSCD95640d00-4047-43cd-b1d7-8aa34fc974cd1
314200pantoprazole 40 MG Delayed Release Oral TabletSCD61cf498c-d6b8-5e26-e053-2991aa0a59c71
314200pantoprazole 40 MG Delayed Release Oral TabletSCD3d081e89-cc4b-411d-8f2a-5ba345e35a371
314200pantoprazole 40 MG Delayed Release Oral TabletSCDbb8add3c-11ed-7096-e053-2995a90a323c1
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY7d77134c-2082-39e8-e053-2991aa0a4a3b1
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY61cf498c-d6b8-5e26-e053-2991aa0a59c71
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY3d081e89-cc4b-411d-8f2a-5ba345e35a371
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSY95640d00-4047-43cd-b1d7-8aa34fc974cd1
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYbb8add3c-11ed-7096-e053-2995a90a323c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-617-43621750617431000 TABLET, DELAYED RELEASE in 1 BOTTLE (62175-617-43) 2011-01-200000-00-00NoNoCurrent
62175-617-466217506174690 TABLET, DELAYED RELEASE in 1 BOTTLE (62175-617-46) 2011-01-200000-00-00NoNoCurrent