Pioglitazone

Product NDC
33342-054
11-digit product format
333420054
Labeler code
33342
Product ID
33342-054_7d118937-d5b2-402f-8e24-f70a48c1d432
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA202467
Marketing category
ANDA
Marketing start
2013-02-14
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
2026-12-31
Current FDA listing
Yes

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
A202467-001PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-06
A202467-002PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-06
A202467-003PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202467-001AB
A202467-002AB
A202467-003AB

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 UTC2026-02A202467-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202467-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202467-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202467-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202467-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202467-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A202467-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202467-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202467-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202467-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202467-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202467-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202467-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202467-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202467-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202467-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202467-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202467-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202467-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202467-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202467-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202467-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202467-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202467-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202467-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202467-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202467-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202467-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A202467-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A202467-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202467-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202467-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202467-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202467-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202467-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202467-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202467-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202467-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202467-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202467-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-068072bd15b7f6…

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 UTC2026-02A202467-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202467-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202467-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202467-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202467-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202467-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202467-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202467-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202467-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202467-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202467-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202467-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202467-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202467-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202467-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202467-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202467-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202467-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202467-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202467-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202467-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202467-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202467-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202467-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202467-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202467-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202467-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202467-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202467-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202467-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202467-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202467-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202467-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202467-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202467-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202467-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202467-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202467-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202467-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202467-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIOGLITAZONE HYDROCHLORIDE15 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312440Internal RxNorm lookup
312441Internal RxNorm lookup
317573Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
482cef76-0623-4b4f-a0ea-f008c97b2281Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-054-07Pioglitazone30 in 1 BOTTLETABLET307
33342-054-10Pioglitazone90 in 1 BOTTLETABLET907
33342-054-12Pioglitazone100 in 1 BOX, UNIT-DOSETABLET1007
33342-054-15Pioglitazone500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-054-07EA - Each33342-054326ebfe7-6c93-4d0d-9756-1f13b95fcf3b12014-06-03
33342-054-10EA - Each33342-05478cae957-04a9-4ba5-923a-f4f17c6abb9012014-06-03
33342-054-15EA - Each33342-054e14170c2-f6d4-4790-a5e6-1704d9b41c9212014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIOGLITAZONE HYDROCHLORIDEACTIVE INGREDIENTJQT35NPK6CPIOGLITAZONE TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
PIOGLITAZONEACTIVE MOIETYX4OV71U42SPIOGLITAZONE TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LPIOGLITAZONE TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPIOGLITAZONE TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPIOGLITAZONE TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIOGLITAZONE TABLET [MACLEODS PHARMACEUTICALS LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-054PIOGLITAZONE TABLET [MACLEODS PHARMACEUTICALS LIMITED]7Current NDC, Legacy NDC, 4 package rows20230101_482cef76-0623-4b4f-a0ea-f008c97b2281.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
PioglitazonePIOGLITAZONENuCare Pharmaceuticals,Inc.af863b9e-9646-3b1e-e053-2995a90ab93a2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202467
application number: ANDA202467
PioglitazonePIOGLITAZONEA-S Medication Solutions9fe57786-5c7d-4b11-8fb4-de341e2e51282023-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202467
application number: ANDA202467
PioglitazonePIOGLITAZONEA-S Medication Solutions4b5506c4-8cc2-44fb-ba2b-0e29fb73943d2023-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202467
application number: ANDA202467
PioglitazonePIOGLITAZONEA-S Medication Solutions475c4f39-dd2a-48f9-a07c-9344bbda58a92023-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202467
application number: ANDA202467
PioglitazonePIOGLITAZONEMacleods Pharmaceuticals Limited482cef76-0623-4b4f-a0ea-f008c97b22812022-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202467
application number: ANDA202467
ndc (product): 33342-054
PioglitazonePIOGLITAZONENorthStar RxLLC692e662a-3b31-42c3-a075-42abe44c74db2022-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202467
application number: ANDA202467

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN482cef76-0623-4b4f-a0ea-f008c97b22817
312440pioglitazone 30 MG Oral TabletPSN482cef76-0623-4b4f-a0ea-f008c97b22817
312441pioglitazone 45 MG Oral TabletPSN482cef76-0623-4b4f-a0ea-f008c97b22817
317573pioglitazone 15 MG Oral TabletSCD482cef76-0623-4b4f-a0ea-f008c97b22817
312440pioglitazone 30 MG Oral TabletSCD482cef76-0623-4b4f-a0ea-f008c97b22817
312441pioglitazone 45 MG Oral TabletSCD482cef76-0623-4b4f-a0ea-f008c97b22817
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY482cef76-0623-4b4f-a0ea-f008c97b22817
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY482cef76-0623-4b4f-a0ea-f008c97b22817
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY482cef76-0623-4b4f-a0ea-f008c97b22817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-054-073334200540730 TABLET in 1 BOTTLE (33342-054-07) 30 tablet2013-02-140000-00-00NoNoCurrent
33342-054-103334200541090 TABLET in 1 BOTTLE (33342-054-10) 90 tablet2013-02-140000-00-00NoNoCurrent
33342-054-1233342005412100 TABLET in 1 BOX, UNIT-DOSE (33342-054-12) 100 tablet2013-02-140000-00-00NoNoCurrent
33342-054-1533342005415500 TABLET in 1 BOTTLE (33342-054-15) 500 tablet2013-02-140000-00-00NoNoCurrent