Pioglitazone

Product NDC
50090-4780
Requested package NDC
50090-4780-0
11-digit product format
500904780
Labeler code
50090
Product ID
50090-4780_be85c821-d443-47c5-857a-9afa6410c5ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077210
Marketing category
ANDA
Marketing start
2015-02-04
Marketing end
0000-00-00
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
15 mg/1
Pharmacologic classes
Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage50090-478050090-4780-0IInactivated 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 · 15 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…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A077210-001PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-10
A077210-002PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-10
A077210-003PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077210-001AB
A077210-002AB
A077210-003AB

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 UTC2026-02A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077210-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2014-01-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077210-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2014-01-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077210-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2014-01-108072bd15b7f6…

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 UTC2026-02A077210-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077210-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077210-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077210-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077210-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077210-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077210-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077210-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077210-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077210-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077210-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077210-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077210-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077210-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077210-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077210-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077210-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077210-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077210-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077210-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077210-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077210-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077210-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077210-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077210-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077210-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077210-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077210-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077210-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077210-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077210-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077210-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077210-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077210-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077210-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077210-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077210-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077210-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077210-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077210-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e11f0f31-8914-938f-521e-037b6de27c13Product name520210621
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ac29cd77-922c-d25a-f8ad-66a8692935c5Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4780-0Pioglitazone30 in 1 BOTTLETABLET303
50090-4780-1Pioglitazone90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4780PIOGLITAZONE TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210416_3817b214-0541-4dd7-82e9-9b95ed7b00fe.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PioglitazonePIOGLITAZONEBryant Ranch Prepackfbdaaa34-06c4-49af-85b4-91a85922b30b2026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077210
application number: ANDA077210
PioglitazonePIOGLITAZONEAvKARE22569835-bc9f-7787-e063-6394a90a62322026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077210
application number: ANDA077210
PioglitazonePIOGLITAZONEAmerican Health Packagingf3a2222d-5156-4533-bb4b-74652c8eb9c72026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077210
application number: ANDA077210
PioglitazonePIOGLITAZONENuCare Pharmaceuticals,Inc.bde7fa79-aafc-3ba0-e053-2a95a90aa4d22025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077210
application number: ANDA077210
PioglitazonePIOGLITAZONENuCare Pharmaceuticals,Inc.a4751cb4-0700-dd22-e053-2995a90adfdb2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077210
application number: ANDA077210
PioglitazonePIOGLITAZONETeva Pharmaceuticals USA, Inc.c5c81c67-90cf-4e64-acb5-58b0358fa7422021-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077210
application number: ANDA077210

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN3817b214-0541-4dd7-82e9-9b95ed7b00fe3
317573pioglitazone 15 MG Oral TabletSCD3817b214-0541-4dd7-82e9-9b95ed7b00fe3
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY3817b214-0541-4dd7-82e9-9b95ed7b00fe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4780-05009047800030 TABLET in 1 BOTTLE (50090-4780-0) 30 tablet2019-12-050000-00-00NoNoCurrent