PIOGLITAZONE HYDROCHLORIDE
- Product NDC
- 65862-514
- 11-digit product format
- 658620514
- Labeler code
- 65862
- Product ID
- 65862-514_75b48749-1268-4752-8a50-83382f05c951
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pioglitazone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA200268
- Marketing category
- ANDA
- Marketing start
- 2013-02-13
- Substance
- PIOGLITAZONE HYDROCHLORIDE
- Active strength
- 45 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
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| unfinished product | product | 65862-514 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-07 | ||
| unfinished package | package | 65862-514 | 65862-514-81 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-07 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished product | product | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 65862-514-81 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished product | product | 1d862106b807… | 00c93037cd84… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 65862-514-81 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished product | product | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 65862-514-81 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | e30019b0c005… | a3f0b14938b7… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 65862-514-81 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 65862-514-81 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 65862-514-81 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | f764e8902f78… | 92046438deef… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 65862-514-81 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 65862-514-81 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished product | product | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 65862-514-81 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished product | product | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 65862-514-81 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished product | product | 27f29a85d7e4… | 1372111e901f… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 65862-514-81 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished product | product | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 65862-514-81 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished product | product | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 65862-514-81 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished product | product | 50b4072663b7… | eae3003ed65e… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 65862-514-81 | 50b4072663b7… | eae3003ed65e… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished product | product | 906f6e251498… | bf70b80e44f0… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished package | package | 65862-514-81 | 906f6e251498… | bf70b80e44f0… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished product | product | 6db9cb8d1e19… | 3449e1ec5b70… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished package | package | 65862-514-81 | 6db9cb8d1e19… | 3449e1ec5b70… |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished product | product | 8fc7167e32ce… | e96bbc724034… | |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished package | package | 65862-514-81 | 8fc7167e32ce… | e96bbc724034… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished product | product | 4184dd79f89f… | 545327b3e20f… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished package | package | 65862-514-81 | 4184dd79f89f… | 545327b3e20f… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished product | product | 4bd3596a7b87… | 5c64c6f6865f… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished package | package | 65862-514-81 | 4bd3596a7b87… | 5c64c6f6865f… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished product | product | 263afe128892… | 91768de4ddbe… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished package | package | 65862-514-81 | 263afe128892… | 91768de4ddbe… |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished product | product | 5b2001dcd8f5… | 54b53d4dc9e4… | |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished package | package | 65862-514-81 | 5b2001dcd8f5… | 54b53d4dc9e4… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A200268-001 | PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | AB | 2013-02-13 | |
| A200268-002 | PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2013-02-13 | |
| A200268-003 | PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | AB | 2013-02-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A200268-001 | AB |
| A200268-002 | AB |
| A200268-003 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A200268-001 | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | AB | 2013-02-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200268-002 | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2013-02-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200268-003 | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | AB | 2013-02-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200268-001 | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | AB | 2013-02-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200268-002 | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2013-02-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200268-003 | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | AB | 2013-02-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200268-001 | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | AB | 2013-02-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200268-002 | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2013-02-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200268-003 | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | AB | 2013-02-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200268-001 | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | AB | 2013-02-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200268-002 | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2013-02-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200268-003 | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | AB | 2013-02-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200268-001 | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | AB | 2013-02-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200268-002 | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2013-02-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200268-003 | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | AB | 2013-02-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200268-001 | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | AB | 2013-02-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200268-002 | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2013-02-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200268-003 | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | AB | 2013-02-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200268-001 | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | AB | 2013-02-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200268-002 | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2013-02-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200268-003 | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | AB | 2013-02-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200268-001 | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | AB | 2013-02-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200268-002 | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2013-02-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200268-003 | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | AB | 2013-02-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200268-001 | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | AB | 2013-02-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200268-002 | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2013-02-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200268-003 | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | AB | 2013-02-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200268-001 | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | AB | 2013-02-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200268-002 | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2013-02-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A200268-003 | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | AB | 2013-02-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200268-001 | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | AB | 2013-02-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200268-002 | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2013-02-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200268-003 | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | AB | 2013-02-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200268-001 | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | AB | 2013-02-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200268-002 | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2013-02-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200268-003 | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | AB | 2013-02-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200268-001 | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | AB | 2013-02-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200268-002 | PIOGLITAZONE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2013-02-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200268-003 | PIOGLITAZONE HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | AB | 2013-02-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A200268-001 | PIOGLITAZONE HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | AB | 2013-02-13 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A200268-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200268-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200268-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200268-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200268-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200268-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A200268-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200268-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200268-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200268-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200268-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200268-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200268-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200268-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200268-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200268-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200268-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200268-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200268-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200268-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200268-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200268-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200268-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200268-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200268-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200268-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200268-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A200268-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200268-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200268-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200268-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200268-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200268-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200268-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200268-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200268-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200268-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200268-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A200268-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A200268-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PIOGLITAZONE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PIOGLITAZONE HYDROCHLORIDE | 45 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| JQT35NPK6C | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1f259863-21fd-4d62-b094-4eff845944df | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e11f0f31-8914-938f-521e-037b6de27c13 | Product name | 5 | 20210621 |
| 3e9b6ece-066b-2ac3-28f7-5e13060e5934 | Product name | 2 | 20151109 |
| 0d79b284-47e8-e90c-f249-892b9b251003 | Product name | 1 | 20140508 |
| 7611093e-8875-33d4-9e3c-f48c7e3af1e8 | Product name | 1 | 20140508 |
| ac29cd77-922c-d25a-f8ad-66a8692935c5 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65862-514-05 | PIOGLITAZONE HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET | 500 | 11 | |
| 65862-514-10 | PIOGLITAZONE HYDROCHLORIDE | 10 in 1 BLISTER PACK | TABLET | 10 | 11 | |
| 65862-514-10 | PIOGLITAZONE HYDROCHLORIDE | 3 in 1 CARTON | TABLET | 3 | 11 | |
| 65862-514-30 | PIOGLITAZONE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | 11 | |
| 65862-514-90 | PIOGLITAZONE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET | 90 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-514-05 | EA - Each | 65862-514 | 122152a2-f85d-48ff-a0a1-5b5c521cd82b | 1 | 2019-10-07 |
| 65862-514-30 | EA - Each | 65862-514 | f1c2641a-8bc8-435a-85f5-2eac296a0365 | 1 | 2013-03-03 |
| 65862-514-90 | EA - Each | 65862-514 | 70a32da2-7056-45a3-b584-0c5fefad2885 | 1 | 2023-07-06 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PIOGLITAZONE HYDROCHLORIDE | ACTIVE INGREDIENT | JQT35NPK6C | PIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED] | 4 | |
| PIOGLITAZONE | ACTIVE MOIETY | X4OV71U42S | PIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED] | 4 | |
| CARBOXYMETHYLCELLULOSE CALCIUM | INACTIVE INGREDIENT | UTY7PDF93L | PIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED] | 4 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | PIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | PIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED] | 4 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pioglitazone | PIOGLITAZONE | Major Pharmaceuticals | 72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | A-S Medication Solutions | 6cd7c8b7-f5d4-423b-ae9f-86541869d8cf | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| Pioglitazone | PIOGLITAZONE | Bryant Ranch Prepack | 466ef4c8-84d4-4ded-8505-a33f12adf31c | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | A-S Medication Solutions | e64b46e5-3c94-4635-908e-cdc2263bd3d4 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| Pioglitazone | PIOGLITAZONE | REMEDYREPACK INC. | 3a9f6777-9b4f-482a-aa4e-4900f9d35b8e | 2026-02-10 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| Pioglitazone | PIOGLITAZONE | REMEDYREPACK INC. | 55f9b2d8-3e78-4e2f-bcf1-d00595078fa1 | 2026-01-30 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | A-S Medication Solutions | 41a9586c-8768-4fc3-bb78-e6d98b09030b | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | A-S Medication Solutions | 29073b0a-1d7e-4354-87c7-e764106978d8 | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | REMEDYREPACK INC. | 04577c39-a9c0-4c66-a775-4c79e2c3dea5 | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| Pioglitazone | PIOGLITAZONE | Preferred Pharmaceuticals, Inc. | 164c444c-7c56-4482-9cbd-0e0f0ad30c44 | 2025-09-09 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| Pioglitazone | PIOGLITAZONE | Preferred Pharmaceuticals, Inc. | 060e3169-46a7-419d-9acc-05586cb2406b | 2025-09-09 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | Bryant Ranch Prepack | c9548800-4c44-473d-a89b-c705484548b3 | 2025-06-27 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| Pioglitazone | PIOGLITAZONE | Bryant Ranch Prepack | 6397fb4c-081b-4abd-ab4b-0a3fbf99e663 | 2025-06-27 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | Aurobindo Pharma Limited | 1f259863-21fd-4d62-b094-4eff845944df | 2025-05-17 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 65862-514 |
| PIOGLITAZONE HYDROCHLORIDE | PIOGLITAZONE HYDROCHLORIDE | QUALLENT PHARMACEUTICALS HEALTH LLC | 0331400c-b163-4856-bfb0-965470247cb3 | 2025-05-17 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| Pioglitazone | PIOGLITAZONE | Rising Pharma Holdings, Inc. | 4483b1c6-7095-4a63-8128-ac2d91e11040 | 2025-05-17 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| PIOGLITAZONE | PIOGLITAZONE | DIRECT RX | a7e8d5a3-b0da-1d70-e053-2a95a90aa435 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| Pioglitazone | PIOGLITAZONE | Bryant Ranch Prepack | f6cad01e-cd65-4c8d-9e49-399404f22005 | 2024-12-10 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| Pioglitazone | PIOGLITAZONE | NuCare Pharmaceuticals,Inc. | a1112e4b-e9d5-13c3-e053-2995a90a6d0a | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
| Pioglitazone | PIOGLITAZONE | NuCare Pharmaceuticals,Inc. | a0846e3e-68b2-fd55-e053-2995a90a673e | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 200268 ANDA200268 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 317573 | pioglitazone 15 MG Oral Tablet | PSN | 1f259863-21fd-4d62-b094-4eff845944df | 11 |
| 312440 | pioglitazone 30 MG Oral Tablet | PSN | 1f259863-21fd-4d62-b094-4eff845944df | 11 |
| 312441 | pioglitazone 45 MG Oral Tablet | PSN | 1f259863-21fd-4d62-b094-4eff845944df | 11 |
| 317573 | pioglitazone 15 MG Oral Tablet | SCD | 1f259863-21fd-4d62-b094-4eff845944df | 11 |
| 312440 | pioglitazone 30 MG Oral Tablet | SCD | 1f259863-21fd-4d62-b094-4eff845944df | 11 |
| 312441 | pioglitazone 45 MG Oral Tablet | SCD | 1f259863-21fd-4d62-b094-4eff845944df | 11 |
| 312441 | pioglitazone (as pioglitazone HCl) 45 MG Oral Tablet | SY | 1f259863-21fd-4d62-b094-4eff845944df | 11 |
| 317573 | pioglitazone (as pioglitazone hydrochloride) 15 MG Oral Tablet | SY | 1f259863-21fd-4d62-b094-4eff845944df | 11 |
| 312440 | pioglitazone (as pioglitazone hydrochloride) 30 MG Oral Tablet | SY | 1f259863-21fd-4d62-b094-4eff845944df | 11 |
| 312441 | pioglitazone 45 MG Oral Tablet | PSN | e64b46e5-3c94-4635-908e-cdc2263bd3d4 | 4 |
| 312441 | pioglitazone 45 MG Oral Tablet | SCD | e64b46e5-3c94-4635-908e-cdc2263bd3d4 | 4 |
| 312441 | pioglitazone (as pioglitazone HCl) 45 MG Oral Tablet | SY | e64b46e5-3c94-4635-908e-cdc2263bd3d4 | 4 |
| 312441 | pioglitazone 45 MG Oral Tablet | PSN | 04577c39-a9c0-4c66-a775-4c79e2c3dea5 | 1 |
| 312441 | pioglitazone 45 MG Oral Tablet | SCD | 04577c39-a9c0-4c66-a775-4c79e2c3dea5 | 1 |
| 312441 | pioglitazone (as pioglitazone HCl) 45 MG Oral Tablet | SY | 04577c39-a9c0-4c66-a775-4c79e2c3dea5 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65862-514-05 | 65862051405 | 500 TABLET in 1 BOTTLE (65862-514-05) | 500 tablet | 2013-02-13 | 0000-00-00 | No | No | Current |
| 65862-514-10 | 65862051410 | 3 BLISTER PACK in 1 CARTON (65862-514-10) / 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2013-02-13 | 0000-00-00 | No | No | Current |
| 65862-514-30 | 65862051430 | 30 TABLET in 1 BOTTLE (65862-514-30) | 30 tablet | 2013-02-13 | 0000-00-00 | No | No | Current |
| 65862-514-81 | 65862051481 | 8000 TABLET in 1 BAG (65862-514-81) | 8000 tablet | 13-FEB-13 | Current | |||
| 65862-514-90 | 65862051490 | 90 TABLET in 1 BOTTLE (65862-514-90) | 90 tablet | 2013-02-13 | 0000-00-00 | No | No | Current |