PANTOPRAZOLE SODIUM

Product NDC
62756-129
11-digit product format
627560129
Labeler code
62756
Product ID
62756-129_ef1bb9ed-b534-4698-abf5-836dcce85f45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PANTOPRAZOLE SODIUM
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077674
Marketing category
ANDA
Marketing start
2019-09-01
Substance
PANTOPRAZOLE SODIUM
Active strength
40 mg/10mL
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
A077674-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUS2019-08-19

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 UTC2026-02A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUS2019-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUS2019-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUS2019-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUS2019-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUS2019-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUS2019-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUS2019-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUS2019-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUS2019-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUS2019-08-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUS2019-08-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUS2019-08-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUS2019-08-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUS2019-08-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2019-08-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2019-08-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2019-08-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / IV (INFUSION)AP2019-08-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2019-08-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2019-08-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / IV (INFUSION)AP2019-08-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / IV (INFUSION)AP2019-08-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / IV (INFUSION)AP2019-08-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / IV (INFUSION)AP2019-08-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / IV (INFUSION)AP2019-08-193f01610625f2…
2019-09-15 20:21 UTC2019-09A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / IV (INFUSION)AP2019-08-19b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUS2019-08-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2019-08-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2019-08-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2019-08-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2019-08-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2019-08-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2019-08-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2019-08-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2019-08-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2019-08-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2019-08-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2019-08-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2019-08-19cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077674-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUS2019-08-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077674-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077674-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077674-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077674-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077674-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077674-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077674-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A077674-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077674-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077674-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077674-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A077674-001AP1b00525d2431f…
2024-02-18 07:12 UTC2024-02A077674-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077674-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077674-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077674-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077674-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077674-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077674-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077674-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077674-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077674-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077674-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077674-001AP1cb3db0bc1861…

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/10mL

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
283669Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9fcf6a2-3788-4955-84d9-3c319b13267cAvailable 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
62756-129-40PANTOPRAZOLE SODIUM1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,18
62756-129-40PANTOPRAZOLE SODIUM10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,108
62756-129-44PANTOPRAZOLE SODIUM10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,108
62756-129-44PANTOPRAZOLE SODIUM10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,108
62756-129-45PANTOPRAZOLE SODIUM1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,18
62756-129-45PANTOPRAZOLE SODIUM25 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,258

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-129-40EA - Each62756-129a92c761b-c02d-4ade-92e4-5758ed2d855f12019-11-12
62756-129-44EA - Each62756-1299b074590-0286-4df6-8b3a-6c603b66b04f12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-129PANTOPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]8Current NDC, Legacy NDC, 6 package rows20250216_d9fcf6a2-3788-4955-84d9-3c319b13267c.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 SODIUMSun Pharmaceutical Industries, Inc.d9fcf6a2-3788-4955-84d9-3c319b13267c2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077674
application number: ANDA077674
ndc (product): 62756-129

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSNd9fcf6a2-3788-4955-84d9-3c319b13267c8
283669pantoprazole 40 MG InjectionSCDd9fcf6a2-3788-4955-84d9-3c319b13267c8
283669pantoprazole (as sodium) 40 MG InjectionSYd9fcf6a2-3788-4955-84d9-3c319b13267c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-129-40627560129401 VIAL in 1 CARTON (62756-129-40) / 10 mL in 1 VIAL1 vial2019-09-010000-00-00NoNoCurrent
62756-129-446275601294410 VIAL in 1 CARTON (62756-129-44) / 10 mL in 1 VIAL10 vial2019-09-010000-00-00NoNoCurrent
62756-129-456275601294525 CARTON in 1 PACKAGE (62756-129-45) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL25 carton2019-09-010000-00-00NoNoCurrent