Cefdinir
- Product NDC
- 70518-2537
- Requested package NDC
- 70518-2537-0
- 11-digit product format
- 705182537
- Labeler code
- 70518
- Product ID
- 70518-2537_dc23fdc1-d32b-1da5-e053-2a95a90a7767
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefdinir
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA065434
- Marketing category
- ANDA
- Marketing start
- 2020-01-11
- Marketing end
- 0000-00-00
- Substance
- CEFDINIR
- Active strength
- 300 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC], Cephalosporins [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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 70518-2537 | 70518-2537-0 | D | Discontinued by firm | 2026-08-03 |
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-2537 | 70518-2537-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-2537 | 70518-2537-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… |
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… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d3e72f63-2c41-955f-f4ce-e90c6403e67c | Product name | 2 | 20210729 |
| e8e66e64-d220-99cb-44eb-0f32dc8cbda1 | Product name | 2 | 20210729 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70518-2537-0 | EA - Each | 70518-2537 | cbad797f-0362-4a1d-845c-55db452f4cd1 | 1 | 2024-04-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-2537 | CEFDINIR CAPSULE [REMEDYREPACK INC.] | 10 | Legacy NDC | 20250112_dff50439-0005-485e-b36e-33cd068b4939.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.
| 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 |
| 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 |
| Cefdinir | CEFDINIR | PD-Rx Pharmaceuticals, Inc. | e296387e-eb20-4451-a184-f91748a4e9c7 | 2025-10-17 | Warnings, Adverse reactions | 065434 ANDA065434 |
| Cefdinir | CEFDINIR | PD-Rx Pharmaceuticals, Inc. | f4f62b64-5350-4b4e-b8f2-381f54a0cd10 | 2025-10-17 | Warnings, Adverse reactions | 065434 ANDA065434 |
| Cefdinir | CEFDINIR | PD-Rx Pharmaceuticals, Inc. | 463084e5-908d-4bbc-b542-10b98211e28e | 2025-10-02 | Warnings, Adverse reactions | 065434 ANDA065434 |
| Cefdinir | CEFDINIR | PD-Rx Pharmaceuticals, Inc. | 3c2130f9-a0d8-4a4e-bcad-36379202b7bb | 2025-10-02 | Warnings, Adverse reactions | 065434 ANDA065434 |
| 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 |
| Cefdinir | CEFDINIR | NuCare Pharmaceuticals,Inc. | 8c3b89a9-cb3f-5960-e053-2995a90aaeee | 2024-06-18 | Warnings, Adverse reactions | 065434 ANDA065434 |
| Cefdinir | CEFDINIR | Rising Pharma Holdings, Inc. | a5594006-8e37-459e-8e85-7e2a83d7a57e | 2024-02-12 | Warnings, Adverse reactions | 065434 ANDA065434 |
| Cefdinir | CEFDINIR | Aurobindo Pharma Limited | df26edb0-9bd6-449c-a187-0be0c9e2600c | 2024-02-12 | Warnings, Adverse reactions | 065434 ANDA065434 |
| Cefdinir | CEFDINIR | A-S Medication Solutions | 7c25ae35-61f4-4aef-a8d9-8de77b02ab80 | 2023-09-12 | Warnings, Adverse reactions | 065434 ANDA065434 |
| Cefdinir | CEFDINIR | Proficient Rx LP | 506bcf51-3b7e-4fc0-b22e-a5b726471e3a | 2023-07-01 | Warnings, Adverse reactions | 065434 ANDA065434 |
| Cefdinir | CEFDINIR | BluePoint Laboratories | e342b7cf-f527-476e-8119-b1fd81c58b55 | 2023-03-29 | Warnings, Adverse reactions | 065434 ANDA065434 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-2537-0 | 70518253700 | 20 CAPSULE in 1 BOTTLE, PLASTIC (70518-2537-0) | 20 capsule | 2020-01-11 | 0000-00-00 | No | No | Current |