Pioglitazone

Product NDC
68071-2373
Requested package NDC
68071-2373-3
11-digit product format
680712373
Labeler code
68071
Product ID
68071-2373_2bb43ca6-01ab-b3e2-e063-6294a90a1a04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA077210
Marketing category
ANDA
Marketing start
2015-02-04
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-02-02 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…

Additional Listing Data#

Finished product
Yes
Brand name base
Pioglitazone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIOGLITAZONE HYDROCHLORIDE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JQT35NPK6CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312440Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bde7fa79-aafc-3ba0-e053-2a95a90aa4d2Available on FDA.report

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
68071-2373-3Pioglitazone30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2373PIOGLITAZONE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 1 package rows20250306_bde7fa79-aafc-3ba0-e053-2a95a90aa4d2.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
ndc (package): 68071-2373-3
ndc (product): 68071-2373
ndc11 (package): 68071237303
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
312440pioglitazone 30 MG Oral TabletPSNbde7fa79-aafc-3ba0-e053-2a95a90aa4d22
312440pioglitazone 30 MG Oral TabletSCDbde7fa79-aafc-3ba0-e053-2a95a90aa4d22
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYbde7fa79-aafc-3ba0-e053-2a95a90aa4d22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2373-36807123730330 TABLET in 1 BOTTLE (68071-2373-3) 30 tablet2021-03-190000-00-00NoNoCurrent