Alogliptin and Pioglitazone

Product NDC
45802-304
Requested package NDC
45802-304-65
11-digit product format
458020304
Labeler code
45802
Product ID
45802-304_35a2f49d-f0e8-4e6a-a9ae-a37484c0e7e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alogliptin Benzoate and Pioglitazone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
NDA022426
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-04-08
Marketing end
0000-00-00
Substance
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
Active strength
13 mg/1; mg/1
Pharmacologic classes
Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage45802-30445802-304-65DDiscontinued by firm2026-08-10

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022426-001OSENIALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDEEQ 25MG BASE;EQ 15MG BASETABLET / ORALRLD2013-01-25
N022426-002OSENIALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDEEQ 25MG BASE;EQ 30MG BASETABLET / ORALRLD2013-01-25
N022426-003OSENIALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDEEQ 25MG BASE;EQ 45MG BASETABLET / ORALRLD, RS2013-01-25
N022426-004OSENIALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDEEQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2013-01-25
N022426-005OSENIALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDEEQ 12.5MG BASE;EQ 30MG BASETABLET / ORALRLD2013-01-25
N022426-006OSENIALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDEEQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2013-01-25

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022426-00178076892028-06-27U-1337Drug substance, Drug product
N022426-00186370792029-06-04Drug product2014-02-13
N022426-00278076892028-06-27U-1337Drug substance, Drug product
N022426-00286370792029-06-04Drug product2014-02-13
N022426-00378076892028-06-27U-1337Drug substance, Drug product
N022426-00386370792029-06-04Drug product2014-02-13
N022426-00478076892028-06-27U-1337Drug substance, Drug product
N022426-00486370792029-06-04Drug product2014-02-13
N022426-00578076892028-06-27U-1337Drug substance, Drug product
N022426-00586370792029-06-04Drug product2014-02-13
N022426-00678076892028-06-27U-1337Drug substance, Drug product
N022426-00686370792029-06-04Drug product2014-02-13

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022426-001OSENIEQ 25MG BASE;EQ 15MG BASETABLET / ORALRLD2013-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022426-002OSENIEQ 25MG BASE;EQ 30MG BASETABLET / ORALRLD2013-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022426-003OSENIEQ 25MG BASE;EQ 45MG BASETABLET / ORALRLD, RS2013-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022426-004OSENIEQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2013-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022426-005OSENIEQ 12.5MG BASE;EQ 30MG BASETABLET / ORALRLD2013-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022426-006OSENIEQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2013-01-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-001OSENIEQ 25MG BASE;EQ 15MG BASETABLET / ORALRLD2013-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-002OSENIEQ 25MG BASE;EQ 30MG BASETABLET / ORALRLD2013-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-003OSENIEQ 25MG BASE;EQ 45MG BASETABLET / ORALRLD, RS2013-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-004OSENIEQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2013-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-005OSENIEQ 12.5MG BASE;EQ 30MG BASETABLET / ORALRLD2013-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-006OSENIEQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2013-01-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N022426-001OSENIEQ 25MG BASE;EQ 15MG BASETABLET / ORALRLD2013-01-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022426-002OSENIEQ 25MG BASE;EQ 30MG BASETABLET / ORALRLD2013-01-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022426-003OSENIEQ 25MG BASE;EQ 45MG BASETABLET / ORALRLD, RS2013-01-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022426-004OSENIEQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2013-01-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022426-005OSENIEQ 12.5MG BASE;EQ 30MG BASETABLET / ORALRLD2013-01-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022426-006OSENIEQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2013-01-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022426-001OSENIEQ 25MG BASE;EQ 15MG BASETABLET / ORALRLD2013-01-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022426-002OSENIEQ 25MG BASE;EQ 30MG BASETABLET / ORALRLD2013-01-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022426-003OSENIEQ 25MG BASE;EQ 45MG BASETABLET / ORALRLD, RS2013-01-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022426-004OSENIEQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2013-01-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022426-005OSENIEQ 12.5MG BASE;EQ 30MG BASETABLET / ORALRLD2013-01-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022426-006OSENIEQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2013-01-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022426-001OSENIEQ 25MG BASE;EQ 15MG BASETABLET / ORALRLD2013-01-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022426-002OSENIEQ 25MG BASE;EQ 30MG BASETABLET / ORALRLD2013-01-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022426-003OSENIEQ 25MG BASE;EQ 45MG BASETABLET / ORALRLD, RS2013-01-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022426-004OSENIEQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2013-01-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022426-005OSENIEQ 12.5MG BASE;EQ 30MG BASETABLET / ORALRLD2013-01-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022426-006OSENIEQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2013-01-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022426-001OSENIEQ 25MG BASE;EQ 15MG BASETABLET / ORALRLD2013-01-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022426-002OSENIEQ 25MG BASE;EQ 30MG BASETABLET / ORALRLD2013-01-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022426-003OSENIEQ 25MG BASE;EQ 45MG BASETABLET / ORALRLD, RS2013-01-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022426-004OSENIEQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2013-01-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022426-005OSENIEQ 12.5MG BASE;EQ 30MG BASETABLET / ORALRLD2013-01-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022426-006OSENIEQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2013-01-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022426-001OSENIEQ 25MG BASE;EQ 15MG BASETABLET / ORALRLD2013-01-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022426-002OSENIEQ 25MG BASE;EQ 30MG BASETABLET / ORALRLD2013-01-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022426-003OSENIEQ 25MG BASE;EQ 45MG BASETABLET / ORALRLD, RS2013-01-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022426-004OSENIEQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2013-01-252680178bc6a6…

Observed Orange Book patent history#

Patent history page 1 of 28 · 1,082 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022426-00178076892028-06-27U-1337Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022426-00186370792029-06-04Drug product2014-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022426-00278076892028-06-27U-1337Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022426-00286370792029-06-04Drug product2014-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022426-00378076892028-06-27U-1337Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022426-00386370792029-06-04Drug product2014-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022426-00478076892028-06-27U-1337Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022426-00486370792029-06-04Drug product2014-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022426-00578076892028-06-27U-1337Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022426-00586370792029-06-04Drug product2014-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022426-00678076892028-06-27U-1337Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022426-00686370792029-06-04Drug product2014-02-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00181736632025-03-15U-133831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00182885392025-03-15Drug substance31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00178076892028-06-27U-1337Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00186370792029-06-04Drug product2014-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00281736632025-03-15U-133831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00282885392025-03-15Drug substance31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00278076892028-06-27U-1337Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00286370792029-06-04Drug product2014-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00381736632025-03-15U-133831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00382885392025-03-15Drug substance31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00378076892028-06-27U-1337Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00386370792029-06-04Drug product2014-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00481736632025-03-15U-133831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00482885392025-03-15Drug substance31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00478076892028-06-27U-1337Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00486370792029-06-04Drug product2014-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00581736632025-03-15U-133831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00582885392025-03-15Drug substance31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00578076892028-06-27U-1337Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00586370792029-06-04Drug product2014-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00681736632025-03-15U-133831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00682885392025-03-15Drug substance31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00678076892028-06-27U-1337Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022426-00686370792029-06-04Drug product2014-02-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N022426-00181736632025-03-15U-13386a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022426-00182885392025-03-15Drug substance6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022426-00178076892028-06-27U-1337Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022426-00186370792029-06-04Drug product2014-02-136a471c1ec25d…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N022426-001M-1772019-04-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022426-002M-1772019-04-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022426-003M-1772019-04-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022426-004M-1772019-04-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022426-005M-1772019-04-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022426-006M-1772019-04-0574a2ff9319b5…
2019-12-14 00:12 UTC2019-12N022426-001M-1772019-04-053f01610625f2…
2019-12-14 00:12 UTC2019-12N022426-002M-1772019-04-053f01610625f2…
2019-12-14 00:12 UTC2019-12N022426-003M-1772019-04-053f01610625f2…
2019-12-14 00:12 UTC2019-12N022426-004M-1772019-04-053f01610625f2…
2019-12-14 00:12 UTC2019-12N022426-005M-1772019-04-053f01610625f2…
2019-12-14 00:12 UTC2019-12N022426-006M-1772019-04-053f01610625f2…
2019-09-15 20:21 UTC2019-09N022426-001M-1772019-04-05b00525d2431f…
2019-09-15 20:21 UTC2019-09N022426-002M-1772019-04-05b00525d2431f…
2019-09-15 20:21 UTC2019-09N022426-003M-1772019-04-05b00525d2431f…
2019-09-15 20:21 UTC2019-09N022426-004M-1772019-04-05b00525d2431f…
2019-09-15 20:21 UTC2019-09N022426-005M-1772019-04-05b00525d2431f…
2019-09-15 20:21 UTC2019-09N022426-006M-1772019-04-05b00525d2431f…
2019-07-19 19:46 UTC2019-07N022426-001M-1772019-04-05ea99ee380514…
2019-07-19 19:46 UTC2019-07N022426-002M-1772019-04-05ea99ee380514…
2019-07-19 19:46 UTC2019-07N022426-003M-1772019-04-05ea99ee380514…
2019-07-19 19:46 UTC2019-07N022426-004M-1772019-04-05ea99ee380514…
2019-07-19 19:46 UTC2019-07N022426-005M-1772019-04-05ea99ee380514…
2019-07-19 19:46 UTC2019-07N022426-006M-1772019-04-05ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-304-65EA - Each45802-3041a3acd8f-58a6-464d-86cf-54ae452c3c9212016-05-16

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alogliptin and PioglitazoneALOGLIPTIN BENZOATE AND PIOGLITAZONE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd642b1e90-701e-42f2-bac6-a4918738e2c92025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022426
application number: NDA022426
OSENIALOGLIPTIN AND PIOGLITAZONETakeda Pharmaceuticals America, Inc.4c619ed9-fe3e-4158-9938-80c6c3493d552025-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022426
application number: NDA022426

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45802-304-654580203046530 TABLET, FILM COATED in 1 BOTTLE (45802-304-65) 2016-04-080000-00-00NoNoCurrent