Pantoprazole Sodium

Product NDC
31722-032
11-digit product format
317220032
Labeler code
31722
Product ID
31722-032_092a2d03-1a01-a7ac-e063-6394a90a01b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
GRANULE, DELAYED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA216139
Marketing category
ANDA
Marketing start
2023-10-27
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216139-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216139-001AB

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
2026-02-19 14:30 UTC2026-02A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-278072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-27a72a2bbeb626…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216139-001PANTOPRAZOLE SODIUMEQ 40MG BASEFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-10-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216139-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216139-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216139-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216139-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216139-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216139-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216139-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216139-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216139-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216139-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216139-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216139-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216139-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216139-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216139-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216139-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216139-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216139-001AB1a72a2bbeb626…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216139-001AB1a50c72e98297…

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
763306Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ee6278c0-d8c0-417c-a65c-b522ff76fe44Available 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
31722-032-32Pantoprazole Sodium1 in 1 PACKETGRANULE, DELAYED RELEASE11
31722-032-32Pantoprazole Sodium30 in 1 CARTONGRANULE, DELAYED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-032-32EA - Each31722-0325fc78912-53e0-417a-8aad-22a2807d57a612024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-032PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20231103_ee6278c0-d8c0-417c-a65c-b522ff76fe44.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMCamber Pharmaceuticals, Inc.ee6278c0-d8c0-417c-a65c-b522ff76fe442023-11-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216139
application number: ANDA216139
ndc (product): 31722-032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763306pantoprazole sodium 40 MG Delayed Release Oral GranulesPSNee6278c0-d8c0-417c-a65c-b522ff76fe441
763306pantoprazole 40 MG Oral GranulesSCDee6278c0-d8c0-417c-a65c-b522ff76fe441
763306pantoprazole 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral GranulesSYee6278c0-d8c0-417c-a65c-b522ff76fe441
763306pantoprazole 40 MG Enteric Coated Oral Granules for Oral SuspensionSYee6278c0-d8c0-417c-a65c-b522ff76fe441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-032-323172200323230 PACKET in 1 CARTON (31722-032-32) / 1 GRANULE, DELAYED RELEASE in 1 PACKET30 packet2023-10-27NoNoCurrent