Application 065434
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFDINIR | CEFDINIR | CAPSULE;ORAL | 300MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065434-001 | CEFDINIR | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065434-001 | 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 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A065434-001 | CEFDINIR | 300MG | CAPSULE / ORAL | AB | 2008-01-07 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A065434-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065434-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065434-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065434-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065434-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065434-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065434-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065434-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065434-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065434-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065434-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065434-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065434-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065434-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065434-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065434-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065434-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065434-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065434-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065434-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065434-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A065434-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A065434-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A065434-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A065434-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A065434-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A065434-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A065434-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A065434-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A065434-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065434-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065434-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065434-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065434-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A065434-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A065434-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065434-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A065434-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A065434-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A065434-001 | AB | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Cefdinir | CEFDINIR | NuCare Pharmaceuticals, Inc. | 5128dc70-f3cd-25c0-e063-6294a90aa52f | 2026-05-06 | Warnings, Adverse reactions | 065434 ANDA065434 |
| Cefdinir | CEFDINIR | Preferred Pharmaceuticals Inc. | c3892cd7-0e98-4ba3-a845-4aedf6c2a830 | 2026-03-24 | Warnings, Adverse reactions | 065434 ANDA065434 68788-7339 |
| Cefdinir | CEFDINIR | Preferred Pharmaceuticals Inc. | 2da6eb80-63b0-4377-8d7b-865733ebbab1 | 2026-03-24 | Warnings, Adverse reactions | 065434 ANDA065434 |
| Cefdinir | CEFDINIR | PD-Rx Pharmaceuticals, Inc. | a5f028d5-ab33-491e-a385-56e79e165150 | 2026-02-24 | Warnings, Adverse reactions | 065434 ANDA065434 |
| Cefdinir | CEFDINIR | REMEDYREPACK INC. | eb354221-c476-41cb-ad87-52423f81d698 | 2026-01-28 | Warnings, Adverse reactions | 065434 ANDA065434 |
| Cefdinir | CEFDINIR | NuCare Pharmaceuticals,Inc. | 9ba5cb2d-6272-27de-e053-2995a90a58c8 | 2025-12-03 | Warnings, Adverse reactions | 065434 ANDA065434 68071-5145 |
| Cefdinir | CEFDINIR | PD-Rx Pharmaceuticals, Inc. | e296387e-eb20-4451-a184-f91748a4e9c7 | 2025-10-17 | Warnings, Adverse reactions | 065434 ANDA065434 43063-959 |
| Cefdinir | CEFDINIR | PD-Rx Pharmaceuticals, Inc. | f4f62b64-5350-4b4e-b8f2-381f54a0cd10 | 2025-10-17 | Warnings, Adverse reactions | 065434 ANDA065434 43063-964 |
| Cefdinir | CEFDINIR | PD-Rx Pharmaceuticals, Inc. | 463084e5-908d-4bbc-b542-10b98211e28e | 2025-10-02 | Warnings, Adverse reactions | 065434 ANDA065434 72789-054 |
| Cefdinir | CEFDINIR | PD-Rx Pharmaceuticals, Inc. | 3c2130f9-a0d8-4a4e-bcad-36379202b7bb | 2025-10-02 | Warnings, Adverse reactions | 065434 ANDA065434 72789-061 |
| Cefdinir | CEFDINIR | Direct_Rx | f431ad55-24c8-e12a-e053-2a95a90aa043 | 2025-01-22 | Warnings, Adverse reactions | 065434 ANDA065434 |
| Cefdinir | CEFDINIR | NuCare Pharmaceuticals,Inc. | 54b06071-f3cb-5627-e054-00144ff8d46c | 2024-07-17 | Warnings, Adverse reactions | 065434 ANDA065434 68071-4007 |
| Cefdinir | CEFDINIR | NuCare Pharmaceuticals,Inc. | 8c3b89a9-cb3f-5960-e053-2995a90aaeee | 2024-06-18 | Warnings, Adverse reactions | 065434 ANDA065434 68071-4946 |
| Cefdinir | CEFDINIR | Rising Pharma Holdings, Inc. | a5594006-8e37-459e-8e85-7e2a83d7a57e | 2024-02-12 | Warnings, Adverse reactions | 065434 ANDA065434 57237-099 |
| Cefdinir | CEFDINIR | Aurobindo Pharma Limited | df26edb0-9bd6-449c-a187-0be0c9e2600c | 2024-02-12 | Warnings, Adverse reactions | 065434 ANDA065434 65862-177 |
| Cefdinir | CEFDINIR | A-S Medication Solutions | 7c25ae35-61f4-4aef-a8d9-8de77b02ab80 | 2023-09-12 | Warnings, Adverse reactions | 065434 ANDA065434 50090-2719 |
| Cefdinir | CEFDINIR | Proficient Rx LP | 506bcf51-3b7e-4fc0-b22e-a5b726471e3a | 2023-07-01 | Warnings, Adverse reactions | 065434 ANDA065434 71205-224 |
| Cefdinir | CEFDINIR | BluePoint Laboratories | e342b7cf-f527-476e-8119-b1fd81c58b55 | 2023-03-29 | Warnings, Adverse reactions | 065434 ANDA065434 68001-362 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10544-194 | Cefdinir | Cefdinir | Blenheim Pharmacal, Inc. | ANDA | Current |
| 16714-391 | Cefdinir | Cefdinir | NorthStar Rx LLC | ANDA | Current |
| 16714-391 | Cefdinir | Cefdinir | NorthStar Rx LLC | ANDA | Current |
| 16714-391 | Cefdinir | Cefdinir | NorthStar Rx LLC | ANDA | Current |
| 21695-620 | Cefdinir | Cefdinir | Rebel Distributors Corp | ANDA | Current |
| 43063-959 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-959 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-959 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-959 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-959 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-959 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-959 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-959 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-964 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-964 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-964 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-964 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-964 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-964 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-964 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-1031 | Cefdinir | Cefdinir | A-S Medication Solutions | ANDA | Current |
| 50090-2636 | Cefdinir | Cefdinir | A-S Medication Solutions | ANDA | Current |
| 50090-2719 | Cefdinir | Cefdinir | A-S Medication Solutions | ANDA | Current |
| 50090-2719 | Cefdinir | Cefdinir | A-S Medication Solutions | ANDA | Current |
| 50090-2719 | Cefdinir | Cefdinir | A-S Medication Solutions | ANDA | Current |
| 50090-2719 | Cefdinir | Cefdinir | A-S Medication Solutions | ANDA | Current |
| 52959-134 | Cefdinir | Cefdinir | H.J. Harkins Company, Inc. | ANDA | Current |
| 53002-1526 | Cefdinir | Cefdinir | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1526 | Cefdinir | Cefdinir | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-171 | Cefdinir | Cefdinir | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-525 | Cefdinir | Cefdinir | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 57237-099 | Cefdinir | Cefdinir | Rising Health, LLC | ANDA | Current |
| 57237-099 | Cefdinir | Cefdinir | Rising Health, LLC | ANDA | Current |
| 57237-099 | Cefdinir | Cefdinir | Rising Health, LLC | ANDA | Current |
| 61919-840 | CEFDINIR | CEFDINIR | DirectRX | ANDA | Current |
| 61919-840 | CEFDINIR | CEFDINIR | DirectRX | ANDA | Current |
| 61919-840 | CEFDINIR | CEFDINIR | DirectRX | ANDA | Current |
| 65862-177 | Cefdinir | Cefdinir | Aurobindo Pharma Limited | ANDA | Current |
| 65862-177 | Cefdinir | Cefdinir | Aurobindo Pharma Limited | ANDA | Current |
| 65862-177 | Cefdinir | Cefdinir | Aurobindo Pharma Limited | ANDA | Current |
| 65862-177 | Cefdinir | Cefdinir | Aurobindo Pharma Limited | ANDA | Current |
| 67296-1216 | Cefdinir | Cefdinir | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1216 | Cefdinir | Cefdinir | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1216 | Cefdinir | Cefdinir | RedPharm Drug, Inc. | ANDA | Current |
| 68001-362 | Cefdinir | Cefdinir | BluePoint Laboratories | ANDA | Current |
| 68071-4007 | Cefdinir | Cefdinir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4007 | Cefdinir | Cefdinir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4946 | Cefdinir | Cefdinir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4946 | Cefdinir | Cefdinir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5145 | Cefdinir | Cefdinir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5145 | Cefdinir | Cefdinir | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7339 | Cefdinir | Cefdinir | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7339 | Cefdinir | Cefdinir | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7339 | Cefdinir | Cefdinir | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7339 | Cefdinir | Cefdinir | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7375 | Cefdinir | Cefdinir | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7606 | Cefdinir | Cefdinir | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7606 | Cefdinir | Cefdinir | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1213 | Cefdinir | Cefdinir | REMEDYREPACK INC. | ANDA | Current |
| 70518-1213 | Cefdinir | Cefdinir | REMEDYREPACK INC. | ANDA | Current |
| 70518-1213 | Cefdinir | Cefdinir | REMEDYREPACK INC. | ANDA | Current |
| 70518-2537 | Cefdinir | Cefdinir | REMEDYREPACK INC. | ANDA | Current |
| 70518-2537 | Cefdinir | Cefdinir | REMEDYREPACK INC. | ANDA | Current |
| 70518-2537 | Cefdinir | Cefdinir | REMEDYREPACK INC. | ANDA | Current |
| 70934-044 | Cefdinir | Cefdinir | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-044 | Cefdinir | Cefdinir | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-062 | Cefdinir | Cefdinir | Denton Pharma, Inc. | ANDA | Current |
| 70934-062 | Cefdinir | Cefdinir | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-062 | Cefdinir | Cefdinir | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-062 | Cefdinir | Cefdinir | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-224 | Cefdinir | Cefdinir | Proficient Rx LP | ANDA | Current |
| 71205-224 | Cefdinir | Cefdinir | Proficient Rx LP | ANDA | Current |
| 71205-224 | Cefdinir | Cefdinir | Proficient Rx LP | ANDA | Current |
| 71205-224 | Cefdinir | Cefdinir | Proficient Rx LP | ANDA | Current |
| 72789-054 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-054 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-054 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-061 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-061 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-061 | Cefdinir | Cefdinir | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |