Cefpodoxime Proxetil
- Product NDC
- 67296-2331
- 11-digit product format
- 672962331
- Labeler code
- 67296
- Product ID
- 67296-2331_5b42e3a1-940a-28ab-e063-6294a90a02ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefpodoxime Proxetil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Redpharm Drug
- Application
- ANDA210568
- Marketing category
- ANDA
- Marketing start
- 2023-03-01
- Substance
- CEFPODOXIME PROXETIL
- Active strength
- 100 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210568-001 | CEFPODOXIME PROXETIL | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | |
| A210568-002 | CEFPODOXIME PROXETIL | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210568-001 | AB |
| A210568-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | 5c6f7cd8ea54… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A210568-001 | CEFPODOXIME PROXETIL | EQ 100MG BASE | TABLET / ORAL | AB | 2022-05-18 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A210568-002 | CEFPODOXIME PROXETIL | EQ 200MG BASE | TABLET / ORAL | AB | 2022-05-18 | ea1830bbd6c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A210568-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210568-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A210568-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210568-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A210568-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210568-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210568-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210568-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210568-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210568-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210568-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210568-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210568-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210568-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210568-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210568-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210568-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210568-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210568-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210568-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210568-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210568-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210568-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210568-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210568-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210568-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210568-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210568-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210568-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210568-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210568-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A210568-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210568-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210568-002 | AB | 1 | 5c6f7cd8ea54… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210568-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210568-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A210568-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A210568-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A210568-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A210568-002 | AB | 1 | ea1830bbd6c7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cefpodoxime Proxetil
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CEFPODOXIME PROXETIL | 100 mg/1 |
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 |
|---|---|---|---|---|---|---|
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | REMEDYREPACK INC. | dae9cbf2-65b5-49fa-898b-924c39b86c57 | 2026-06-04 | Warnings, Adverse reactions | 210568 ANDA210568 |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | Golden State Medical Supply, Inc. | fb313728-09f1-aff8-e053-6394a90a30a8 | 2025-02-18 | Warnings, Adverse reactions | 210568 ANDA210568 |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | NuCare Pharmaceuticals,Inc. | fe827f61-9336-72e7-e053-6394a90af75f | 2025-02-06 | Warnings, Adverse reactions | 210568 ANDA210568 |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | NuCare Pharmaceuticals,Inc. | 1b405104-650b-c8e3-e063-6294a90a9e8a | 2024-06-19 | Warnings, Adverse reactions | 210568 ANDA210568 |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | Amici Pharmaceuticals, LLC. | 9d6d7f50-9838-47e3-8214-53e2dbeeadea | 2023-07-13 | Warnings, Adverse reactions | 210568 ANDA210568 |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | Ascend Laboratories, LLC | ce5646cb-a450-4c2c-8499-6ecf71b12b0e | 2023-04-14 | Warnings, Adverse reactions | 210568 ANDA210568 |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | Ascend Laboratories, LLC | 5d5ca5b6-282b-4683-908c-854782255739 | 2022-05-20 | Warnings, Adverse reactions | 210568 ANDA210568 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 67296-2331-1 | 67296233101 | 10 TABLET, FILM COATED in 1 BOTTLE (67296-2331-1) | 2023-03-01 | No | No | Current |