Cefdinir
- Product NDC
- 0093-4136
- 11-digit product format
- 000934136
- Labeler code
- 0093
- Product ID
- 0093-4136_7f269e55-b085-4315-807a-e425f0189b2c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefdinir
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA065332
- Marketing category
- ANDA
- Marketing start
- 2007-05-08
- Substance
- CEFDINIR MONOHYDRATE
- Active strength
- 125 mg/5mL
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065332-001 | CEFDINIR | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | |
| A065332-002 | CEFDINIR | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065332-001 | AB |
| A065332-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065332-001 | CEFDINIR | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065332-002 | CEFDINIR | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2007-05-04 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A065332-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065332-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065332-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065332-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065332-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065332-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065332-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065332-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065332-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065332-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065332-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065332-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065332-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065332-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065332-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065332-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065332-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065332-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065332-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065332-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065332-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065332-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065332-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065332-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065332-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065332-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065332-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065332-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065332-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065332-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065332-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065332-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065332-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065332-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065332-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065332-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065332-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065332-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065332-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A065332-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cefdinir
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CEFDINIR MONOHYDRATE | 125 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6E7SN358SE | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a1f49fe1-b511-4f6b-a912-8ae8662d95a5 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| d3e72f63-2c41-955f-f4ce-e90c6403e67c | Product name | 2 | 20210729 |
| e8e66e64-d220-99cb-44eb-0f32dc8cbda1 | Product name | 2 | 20210729 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0093-4136-64 | Cefdinir | 60 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 60 | 15 | |
| 0093-4136-73 | Cefdinir | 100 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 100 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0093-4136-64 | ML - Milliliter | 0093-4136 | 852b3ef8-9e22-480d-87e5-8a9b1ab30766 | 1 | 2012-07-24 |
| 0093-4136-73 | ML - Milliliter | 0093-4136 | 8621fbc6-f208-4753-a1c5-78cee429c3aa | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Cefdinir | CEFDINIR | Preferred Pharmaceuticals Inc. | 0d1212c9-604f-4999-8f7d-e7cf300705ef | 2026-03-24 | Warnings, Adverse reactions | 065332 ANDA065332 |
| Cefdinir | CEFDINIR | A-S Medication Solutions | 1d58b10c-b253-4925-8681-580aa2e8ae2e | 2025-08-13 | Warnings, Adverse reactions | 065332 ANDA065332 |
| Cefdinir | CEFDINIR | NuCare Pharmaceuticals, Inc. | 4ade94bb-6c39-13cd-e054-00144ff8d46c | 2025-02-04 | Warnings, Adverse reactions | 065332 ANDA065332 |
| Cefdinir | CEFDINIR | Teva Pharmaceuticals USA, Inc. | a1f49fe1-b511-4f6b-a912-8ae8662d95a5 | 2023-02-01 | Warnings, Adverse reactions | 065332 ANDA065332 0093-4136 |
| Cefdinir | CEFDINIR | Proficient Rx LP | f22acd90-5dc4-406d-af78-5f9c3a674647 | 2022-03-01 | Warnings, Adverse reactions | 065332 ANDA065332 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309054 | cefdinir 125 MG in 5 mL Oral Suspension | PSN | a1f49fe1-b511-4f6b-a912-8ae8662d95a5 | 15 |
| 476576 | cefdinir 250 MG in 5 mL Oral Suspension | PSN | a1f49fe1-b511-4f6b-a912-8ae8662d95a5 | 15 |
| 309054 | cefdinir 25 MG/ML Oral Suspension | SCD | a1f49fe1-b511-4f6b-a912-8ae8662d95a5 | 15 |
| 476576 | cefdinir 50 MG/ML Oral Suspension | SCD | a1f49fe1-b511-4f6b-a912-8ae8662d95a5 | 15 |
| 309054 | cefdinir 125 MG per 5 ML Oral Suspension | SY | a1f49fe1-b511-4f6b-a912-8ae8662d95a5 | 15 |
| 476576 | cefdinir 250 MG per 5 ML Oral Suspension | SY | a1f49fe1-b511-4f6b-a912-8ae8662d95a5 | 15 |
| 309054 | cefdinir 125 MG in 5 mL Oral Suspension | PSN | 1d58b10c-b253-4925-8681-580aa2e8ae2e | 12 |
| 309054 | cefdinir 25 MG/ML Oral Suspension | SCD | 1d58b10c-b253-4925-8681-580aa2e8ae2e | 12 |
| 309054 | cefdinir 125 MG per 5 ML Oral Suspension | SY | 1d58b10c-b253-4925-8681-580aa2e8ae2e | 12 |
| 309054 | cefdinir 125 MG in 5 mL Oral Suspension | PSN | 4ade94bb-6c39-13cd-e054-00144ff8d46c | 6 |
| 309054 | cefdinir 25 MG/ML Oral Suspension | SCD | 4ade94bb-6c39-13cd-e054-00144ff8d46c | 6 |
| 309054 | cefdinir 125 MG per 5 ML Oral Suspension | SY | 4ade94bb-6c39-13cd-e054-00144ff8d46c | 6 |
| 309054 | cefdinir 125 MG in 5 mL Oral Suspension | PSN | c335ee41-a4fe-43c9-bf21-91b24992378c | 3 |
| 309054 | cefdinir 25 MG/ML Oral Suspension | SCD | c335ee41-a4fe-43c9-bf21-91b24992378c | 3 |
| 309054 | cefdinir 125 MG per 5 ML Oral Suspension | SY | c335ee41-a4fe-43c9-bf21-91b24992378c | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0093-4136-64 | 00093413664 | 60 mL in 1 BOTTLE (0093-4136-64) | 60 ml | 2007-05-08 | 0000-00-00 | No | No | Current |
| 0093-4136-73 | 00093413673 | 100 mL in 1 BOTTLE (0093-4136-73) | 100 ml | 2007-05-08 | 0000-00-00 | No | No | Current |