FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
51079-051
11-digit product format
510790051
Labeler code
51079
Product ID
51079-051_3a875ad3-8a73-b446-e063-6294a90a1a63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pantoprazole sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA090970
Marketing category
ANDA
Marketing start
2011-02-23
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
A090970-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19
A090970-002PANTOPRAZOLE 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
A090970-001AB
A090970-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090970-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19a50c72e98297…
2026-08-01 22:54:322026-06A090970-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2011-01-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090970-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A090970-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMSafecor Health LLC5e1cbf26-d379-4315-8732-3939968f32c02026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole SodiumPANTOPRAZOLE SODIUMCardinal Health 107, LLCe17e4a72-d6a4-4a83-a921-88af9ef028a62026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole SodiumPANTOPRAZOLE SODIUMQPharma Incfbd035d0-529c-6033-e053-6294a90abf072025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole SodiumPANTOPRAZOLE SODIUMMylan Institutional Inc.a9b0d279-118b-4372-bd51-d4bad9c1cfca2025-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
ndc (product): 51079-051
Pantoprazole Sodium DRPANTOPRAZOLE SODIUMAdvanced Rx Pharmacy of Tennessee, LLCd27e1fdd-e23f-0d60-e053-2a95a90a90872024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole SodiumPANTOPRAZOLE SODIUMNCS HealthCare of KY, LLC dba Vangard Labs6faf465b-c3a3-4ae7-9e16-1ba758f6962a2024-09-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole SodiumPANTOPRAZOLE SODIUMBryant Ranch Prepack7d51104d-b135-421f-8425-03b5772e71032024-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970
Pantoprazole SodiumPANTOPRAZOLE SODIUMMylan Pharmaceuticals Inc.56ad5b97-8e5f-48a5-b2ba-a5484b43d0182023-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090970
application number: ANDA090970

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANTOPRAZOLE SODIUM40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6871619Q5XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
314200Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a9b0d279-118b-4372-bd51-d4bad9c1cfcaAvailable 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
51079-051-01Pantoprazole Sodium1 in 1 BLISTER PACKTABLET, DELAYED RELEASE119
51079-051-20Pantoprazole Sodium100 in 1 CARTONTABLET, DELAYED RELEASE10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-051-01EA - Each51079-051fc203979-3353-418f-b463-d671bb79dbc412012-07-24
51079-051-20EA - Each51079-0515b1a369c-e196-4fc9-bce7-82715039ff2312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]4
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]4
AMMONIAINACTIVE INGREDIENT5138Q19F1XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]4
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]4
MANNITOLINACTIVE INGREDIENT3OWL53L36APANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]4
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]4
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
MANNITOLINACTIVE INGREDIENT3OWL53L36APANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [CARDINAL HEALTH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-051PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]18Current NDC, Legacy NDC, 2 package rows20241011_a9b0d279-118b-4372-bd51-d4bad9c1cfca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNa9b0d279-118b-4372-bd51-d4bad9c1cfca19
314200pantoprazole 40 MG Delayed Release Oral TabletSCDa9b0d279-118b-4372-bd51-d4bad9c1cfca19
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYa9b0d279-118b-4372-bd51-d4bad9c1cfca19
314200pantoprazole sodium 40 MG Delayed Release Oral TabletPSNe17e4a72-d6a4-4a83-a921-88af9ef028a614
314200pantoprazole 40 MG Delayed Release Oral TabletSCDe17e4a72-d6a4-4a83-a921-88af9ef028a614
314200pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral TabletSYe17e4a72-d6a4-4a83-a921-88af9ef028a614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-051-01510790051011 in 1 BLISTER PACKHistorical
51079-051-2051079005120100 BLISTER PACK in 1 CARTON (51079-051-20) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (51079-051-01) 100 blister pack2011-02-230000-00-00NoNoCurrent