Pantoprazole Sodium

Product NDC
0615-7916
11-digit product format
006157916
Labeler code
0615
Product ID
0615-7916_c0d42cf9-78d2-40c6-ab6f-59ce0dd2f695
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA077056
Marketing category
ANDA
Marketing start
2007-12-21
Marketing end
0000-00-00
Substance
PANTOPRAZOLE SODIUM
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-7916DDiscontinued by firm2026-08-03
excluded packagepackage0615-79160615-7916-39DDiscontinued by firm2026-08-03

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-7916-39DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-7916-39DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-7916-39DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-7916-39DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-7916-39DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-7916-39DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-7916-39DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-7916-39DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-7916-39DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-7916-39DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-7916-39DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-7916-39DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0615-7916-39IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0615-7916-39IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0615-7916-39EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A077056-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02
A077056-002PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02

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 UTC2026-02A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALAB2007-08-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORALAB2007-08-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077056-001PANTOPRAZOLE SODIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02782e0a99824c…
2021-12-28 21:50 UTC2021-12A077056-002PANTOPRAZOLE SODIUMEQ 40MG BASETABLET, DELAYED RELEASE / ORAL2007-08-02782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077056-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077056-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A077056-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077056-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077056-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077056-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077056-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077056-002AB1ea99ee380514…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PANTOPRAZOLE SODIUMACTIVE INGREDIENT6871619Q5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
PANTOPRAZOLEACTIVE MOIETYD8TST4O562PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
SHELLACINACTIVE INGREDIENT46N107B71OPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1