Pioglitazone

Product NDC
71335-1137
11-digit product format
713351137
Labeler code
71335
Product ID
71335-1137_95b1666b-7f41-4b65-8995-a485afb2bd98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-1137IInactivated by FDA2026-08-07
excluded packagepackage71335-113771335-1137-1IInactivated by FDA2026-08-07
excluded packagepackage71335-113771335-1137-2IInactivated by FDA2026-08-07
excluded packagepackage71335-113771335-1137-3IInactivated by FDA2026-08-07
excluded packagepackage71335-113771335-1137-4IInactivated 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 2 · 75 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1137-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1137-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1137-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1137-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1137-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1137-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1137-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1137-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1137-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1137-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1137-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1137-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1137-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1137-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1137-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1137-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1137-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1137-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1137-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1137-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1137-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1137-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1137-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1137-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1137-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1137-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1137-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1137-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1137-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1137-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1137-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1137-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1137-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1137-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1137-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1137-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1137-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1137-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1137-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1137-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1137-4367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1137-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1137-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1137-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1137-4557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1137-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1137-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1137-2557ba5c1ecfa…9c80585c8c6e…

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
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
71335-1137-1Pioglitazone30 in 1 BOTTLETABLET308
71335-1137-2Pioglitazone90 in 1 BOTTLETABLET908
71335-1137-3Pioglitazone60 in 1 BOTTLETABLET608
71335-1137-4Pioglitazone120 in 1 BOTTLETABLET1208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1137PIOGLITAZONE TABLET [BRYANT RANCH PREPACK]8Legacy NDC, 4 package rows20220204_95b1666b-7f41-4b65-8995-a485afb2bd98.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 TabletPSN95b1666b-7f41-4b65-8995-a485afb2bd988
317573pioglitazone 15 MG Oral TabletSCD95b1666b-7f41-4b65-8995-a485afb2bd988
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY95b1666b-7f41-4b65-8995-a485afb2bd988

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1137-17133511370130 TABLET in 1 BOTTLE (71335-1137-1) 30 tablet2019-09-110000-00-00NoNoCurrent
71335-1137-27133511370290 TABLET in 1 BOTTLE (71335-1137-2) 90 tablet2019-03-040000-00-00NoNoCurrent
71335-1137-37133511370360 TABLET in 1 BOTTLE (71335-1137-3) 60 tablet2021-12-280000-00-00NoNoCurrent
71335-1137-471335113704120 TABLET in 1 BOTTLE (71335-1137-4) 120 tablet2021-12-280000-00-00NoNoCurrent