Application 050749
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OMNICEF | CEFDINIR | FOR SUSPENSION;ORAL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | OMNICEF | CEFDINIR | FOR SUSPENSION;ORAL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050749-001 | OMNICEF | CEFDINIR | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | |
| N050749-002 | OMNICEF | CEFDINIR | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 |
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| 2026-08 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050749-001 | OMNICEF | 125MG/5ML | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050749-002 | OMNICEF | 250MG/5ML | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050749-001 | OMNICEF | 125MG/5ML | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050749-002 | OMNICEF | 250MG/5ML | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050749-001 | OMNICEF | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | FOR SUSPENSION / ORAL | RLD | 1997-12-04 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050749-002 | OMNICEF | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | FOR SUSPENSION / ORAL | RLD | 2004-07-29 | 74a2ff9319b5… |
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 | DIRECT RX | 982d0f53-20bc-1cb4-e053-2995a90ad33c | 2025-01-22 | Warnings | CEFDINIR |
| CEFDINIR | CEFDINIR | DirectRx | d70b9e1f-908f-b570-e053-2995a90af098 | 2025-01-21 | Warnings, Adverse reactions | CEFDINIR |
| Cefdinir | CEFDINIR | NuCare Pharmaceuticals,Inc. | c974d975-8616-3551-e053-2995a90a65f3 | 2025-01-14 | Warnings, Adverse reactions | CEFDINIR |
| Cefdinir | CEFDINIR | NuCare Pharmaceuticals,Inc. | 54b06071-f3cb-5627-e054-00144ff8d46c | 2024-07-17 | Warnings, Adverse reactions | CEFDINIR |
| Cefdinir | CEFDINIR | NuCare Pharmaceuticals,Inc. | 1bbd75ea-5a50-eb00-e063-6394a90a1cec | 2024-06-25 | Warnings | CEFDINIR |
| Cefdinir | CEFDINIR | NuCare Pharmaceuticals,Inc. | 96cad498-70d3-3089-e053-2995a90a9d19 | 2024-06-19 | Warnings, Adverse reactions | CEFDINIR |
| Cefdinir | CEFDINIR | NuCare Pharmaceuticals,Inc. | 8c3b89a9-cb3f-5960-e053-2995a90aaeee | 2024-06-18 | Warnings, Adverse reactions | CEFDINIR |
| Cefdinir | CEFDINIR | NuCare Pharmaceuticals,Inc. | 8dfbad95-4dd8-01fd-e053-2a95a90a1de1 | 2024-06-18 | Warnings, Adverse reactions | CEFDINIR |
| Cefdinir | CEFDINIR | American Health Packaging | c493e78b-afa3-4f74-8305-75e5f3817df0 | 2024-06-07 | Warnings, Adverse reactions | CEFDINIR |
| Cefdinir | CEFDINIR | A-S Medication Solutions | beeb9480-f9f9-44ae-93f3-6f4da81888f5 | 2024-02-27 | Warnings, Adverse reactions | CEFDINIR |
| Cefdinir | CEFDINIR | Aurobindo Pharma Limited | 06fbdb63-d32f-4212-9962-f1de15597dda | 2024-02-14 | Warnings, Adverse reactions | CEFDINIR |
| Cefdinir | CEFDINIR | Rising Pharma Holdings, Inc. | a5594006-8e37-459e-8e85-7e2a83d7a57e | 2024-02-12 | Warnings, Adverse reactions | CEFDINIR |
| Cefdinir | CEFDINIR | Aurobindo Pharma Limited | df26edb0-9bd6-449c-a187-0be0c9e2600c | 2024-02-12 | Warnings, Adverse reactions | CEFDINIR |
| Cefdinir | CEFDINIR | A-S Medication Solutions | 10bf69e7-5f7e-4448-9f22-777f137d9666 | 2023-12-25 | Warnings, Adverse reactions | CEFDINIR |
| cefdinir | CEFDINIR | A-S Medication Solutions | 7bbcc4ac-c964-4c6b-88c0-11c0ba9933db | 2023-11-24 | Warnings, Adverse reactions | CEFDINIR |
| Cefdinir | CEFDINIR | A-S Medication Solutions | a217d454-4ca0-4b29-8a64-eb9393a85269 | 2023-11-21 | Warnings, Adverse reactions | CEFDINIR |
| Cefdinir | CEFDINIR | A-S Medication Solutions | 37b5d000-db9e-4b6e-8208-6361e98fb55d | 2023-11-01 | Warnings | CEFDINIR |
| Cefdinir | CEFDINIR | A-S Medication Solutions | 7c25ae35-61f4-4aef-a8d9-8de77b02ab80 | 2023-09-12 | Warnings, Adverse reactions | CEFDINIR |
| Cefdinir | CEFDINIR | Proficient Rx LP | 506bcf51-3b7e-4fc0-b22e-a5b726471e3a | 2023-07-01 | Warnings, Adverse reactions | CEFDINIR |
| Cefdinir | CEFDINIR | A-S Medication Solutions | fb02aaab-d2a0-466e-8327-72e3df1e4e9d | 2023-04-04 | Warnings, Adverse reactions | CEFDINIR |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8173 | SUPPL | 2015-11-20 |
| 39243 | SUPPL | 2015-11-19 |
| 18169 | SUPPL | 2009-01-02 |
| 30438 | SUPPL | 2008-12-19 |
| 30437 | SUPPL | 2007-09-25 |
| 39242 | SUPPL | 2007-09-19 |
| 8172 | SUPPL | 2007-07-05 |
| 18168 | SUPPL | 2007-06-27 |
| 22216 | ORIG | 2006-01-03 |
| 39241 | SUPPL | 2005-07-21 |
| 8171 | SUPPL | 2005-07-21 |
| 30436 | SUPPL | 2004-09-03 |
| 8170 | SUPPL | 2004-07-30 |
| 30435 | SUPPL | 1999-07-14 |
| 18167 | SUPPL | 1999-07-14 |