Pioglitazone

Product NDC
16714-646
11-digit product format
167140646
Labeler code
16714
Product ID
16714-646_099c78c5-8f25-4dc6-a713-b934d0067438
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA202467
Marketing category
ANDA
Marketing start
2022-08-18
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
30 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 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 · 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
692e662a-3b31-42c3-a075-42abe44c74dbAvailable 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
16714-646-01Pioglitazone30 in 1 BOTTLETABLET302
16714-646-02Pioglitazone90 in 1 BOTTLETABLET902
16714-646-03Pioglitazone500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-646-01EA - Each16714-646c7f3cdd9-271e-48f0-99c5-58723ec7ccc512023-01-09
16714-646-02EA - Each16714-6462bc5a65b-3394-4aaa-865c-4f0789483f1b12023-01-09
16714-646-03EA - Each16714-646501b3a82-77a4-424b-9543-0ef3c5802a4b12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-646PIOGLITAZONE TABLET [NORTHSTAR RXLLC]2Current NDC, Legacy NDC, 3 package rows20220909_692e662a-3b31-42c3-a075-42abe44c74db.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
PioglitazonePIOGLITAZONENorthStar RxLLC692e662a-3b31-42c3-a075-42abe44c74db2022-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202467
application number: ANDA202467
ndc (product): 16714-646

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN692e662a-3b31-42c3-a075-42abe44c74db2
312440pioglitazone 30 MG Oral TabletPSN692e662a-3b31-42c3-a075-42abe44c74db2
312441pioglitazone 45 MG Oral TabletPSN692e662a-3b31-42c3-a075-42abe44c74db2
317573pioglitazone 15 MG Oral TabletSCD692e662a-3b31-42c3-a075-42abe44c74db2
312440pioglitazone 30 MG Oral TabletSCD692e662a-3b31-42c3-a075-42abe44c74db2
312441pioglitazone 45 MG Oral TabletSCD692e662a-3b31-42c3-a075-42abe44c74db2
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY692e662a-3b31-42c3-a075-42abe44c74db2
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY692e662a-3b31-42c3-a075-42abe44c74db2
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY692e662a-3b31-42c3-a075-42abe44c74db2
312440pioglitazone 30 MG Oral TabletPSN4b5506c4-8cc2-44fb-ba2b-0e29fb73943d1
312440pioglitazone 30 MG Oral TabletPSN9fe57786-5c7d-4b11-8fb4-de341e2e51281
312440pioglitazone 30 MG Oral TabletSCD4b5506c4-8cc2-44fb-ba2b-0e29fb73943d1
312440pioglitazone 30 MG Oral TabletSCD9fe57786-5c7d-4b11-8fb4-de341e2e51281
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY4b5506c4-8cc2-44fb-ba2b-0e29fb73943d1
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY9fe57786-5c7d-4b11-8fb4-de341e2e51281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-646-011671406460130 TABLET in 1 BOTTLE (16714-646-01) 30 tablet2022-08-180000-00-00NoNoCurrent
16714-646-021671406460290 TABLET in 1 BOTTLE (16714-646-02) 90 tablet2022-08-180000-00-00NoNoCurrent
16714-646-0316714064603500 TABLET in 1 BOTTLE (16714-646-03) 500 tablet2022-08-180000-00-00NoNoCurrent