Pioglitazone

Product NDC
68071-2886
11-digit product format
680712886
Labeler code
68071
Product ID
68071-2886_ee00c2b1-e744-2e85-e053-2995a90aa68c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA200268
Marketing category
ANDA
Marketing start
2013-02-13
Marketing end
0000-00-00
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
15 mg/1
Pharmacologic classes
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-2886IInactivated by FDA2026-08-07
excluded packagepackage68071-288668071-2886-3IInactivated by FDA2026-08-07

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 · 18 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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2886-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2886-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2886-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2886-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2886-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2886-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2886-3UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2886-3UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2886-3UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200268-001PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13
A200268-002PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13
A200268-003PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A200268-001AB
A200268-002AB
A200268-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200268-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200268-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200268-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-138072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200268-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200268-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200268-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200268-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200268-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200268-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200268-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200268-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200268-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200268-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200268-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200268-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200268-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200268-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200268-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200268-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200268-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200268-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200268-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200268-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200268-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200268-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200268-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200268-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200268-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200268-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200268-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200268-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200268-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200268-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200268-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200268-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200268-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200268-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200268-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200268-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200268-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200268-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200268-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200268-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e11f0f31-8914-938f-521e-037b6de27c13Product name520210621
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
ac29cd77-922c-d25a-f8ad-66a8692935c5Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2886-3Pioglitazone30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2886PIOGLITAZONE TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20221124_ee00c2b1-e777-2e85-e053-2995a90aa68c.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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PioglitazonePIOGLITAZONEMajor Pharmaceuticals72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f2026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEA-S Medication Solutions6cd7c8b7-f5d4-423b-ae9f-86541869d8cf2026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PioglitazonePIOGLITAZONEBryant Ranch Prepack466ef4c8-84d4-4ded-8505-a33f12adf31c2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEA-S Medication Solutionse64b46e5-3c94-4635-908e-cdc2263bd3d42026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PioglitazonePIOGLITAZONEREMEDYREPACK INC.3a9f6777-9b4f-482a-aa4e-4900f9d35b8e2026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PioglitazonePIOGLITAZONEREMEDYREPACK INC.55f9b2d8-3e78-4e2f-bcf1-d00595078fa12026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEA-S Medication Solutions41a9586c-8768-4fc3-bb78-e6d98b09030b2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEA-S Medication Solutions29073b0a-1d7e-4354-87c7-e764106978d82026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEREMEDYREPACK INC.04577c39-a9c0-4c66-a775-4c79e2c3dea52025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PioglitazonePIOGLITAZONEPreferred Pharmaceuticals, Inc.164c444c-7c56-4482-9cbd-0e0f0ad30c442025-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PioglitazonePIOGLITAZONEPreferred Pharmaceuticals, Inc.060e3169-46a7-419d-9acc-05586cb2406b2025-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEBryant Ranch Prepackc9548800-4c44-473d-a89b-c705484548b32025-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PioglitazonePIOGLITAZONEBryant Ranch Prepack6397fb4c-081b-4abd-ab4b-0a3fbf99e6632025-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEAurobindo Pharma Limited1f259863-21fd-4d62-b094-4eff845944df2025-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEQUALLENT PHARMACEUTICALS HEALTH LLC0331400c-b163-4856-bfb0-965470247cb32025-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PioglitazonePIOGLITAZONERising Pharma Holdings, Inc.4483b1c6-7095-4a63-8128-ac2d91e110402025-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PIOGLITAZONEPIOGLITAZONEDIRECT RXa7e8d5a3-b0da-1d70-e053-2a95a90aa4352025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PioglitazonePIOGLITAZONEBryant Ranch Prepackf6cad01e-cd65-4c8d-9e49-399404f220052024-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PioglitazonePIOGLITAZONENuCare Pharmaceuticals,Inc.a1112e4b-e9d5-13c3-e053-2995a90a6d0a2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268
PioglitazonePIOGLITAZONENuCare Pharmaceuticals,Inc.a0846e3e-68b2-fd55-e053-2995a90a673e2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200268
application number: ANDA200268

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSNee00c2b1-e777-2e85-e053-2995a90aa68c1
317573pioglitazone 15 MG Oral TabletSCDee00c2b1-e777-2e85-e053-2995a90aa68c1
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSYee00c2b1-e777-2e85-e053-2995a90aa68c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2886-36807128860330 TABLET in 1 BOTTLE (68071-2886-3) 30 tablet2022-11-210000-00-00NoNoCurrent