Cephalexin
- Product NDC
- 70518-4511
- Requested package NDC
- 70518-4511-0
- 11-digit product format
- 705184511
- Labeler code
- 70518
- Product ID
- 70518-4511_5b870337-c133-dd79-e063-6394a90a03ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cephalexin
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA210221
- Marketing category
- ANDA
- Marketing start
- 2025-10-28
- Substance
- CEPHALEXIN
- Active strength
- 250 mg/5mL
- 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 |
|---|---|---|---|---|---|---|---|
| A210221-001 | CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | |
| A210221-002 | CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210221-001 | AB |
| A210221-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210221-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210221-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2019-03-26 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A210221-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A210221-002 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A210221-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210221-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A210221-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210221-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A210221-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210221-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210221-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210221-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210221-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210221-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210221-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210221-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210221-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210221-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210221-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210221-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210221-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210221-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210221-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210221-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210221-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210221-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210221-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210221-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210221-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210221-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210221-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210221-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210221-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210221-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210221-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A210221-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210221-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210221-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A210221-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A210221-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A210221-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A210221-002 | AB | 1 | 4b0b4de00fa7… |
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
- Cephalexin
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CEPHALEXIN | 250 mg/5mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dfa3f520-409c-432e-b6d3-9250d468c772 | Product name | 1 | 20250401 |
| 64bb7f1a-2c2e-4741-8301-dbfeda7239f6 | Product name | 1 | 20190628 |
| 398aa563-bb78-fe0f-46a8-757c40ef28bf | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70518-4511-0 | Cephalexin | 100 mL in 1 BOTTLE | FOR SUSPENSION | 100 | 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 |
|---|---|---|---|---|---|---|
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 06c2fb2e-0539-4f16-bac4-e15a575ca802 | 2026-04-03 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | Preferred Pharmaceuticlas Inc. | fbf5fcdf-40fc-40e5-b784-308032fff0e5 | 2026-03-25 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | Preferred Pharmaceuticals, Inc. | 6c7bfa58-2d38-4607-8c33-485ba4931c68 | 2026-03-25 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | ee278959-d321-d356-e053-2995a90a32c2 | 2026-01-30 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | c7028200-b141-496b-89e9-491558d4c879 | 2025-11-10 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 5f867aa3-ea64-4a14-a63b-979b8ff8d80c | 2025-11-07 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 8d7f247a-3b42-4823-96fb-5f5c1bd94d49 | 2025-08-29 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 1bfa8744-24ee-4c70-845c-c532b8084433 | 2025-07-29 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | a8f14231-5d43-46f7-ba1f-d6de8162d5e7 | 2024-11-20 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | e186afb5-7531-45ea-b785-c230483a7747 | 2024-08-20 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | f1439d25-3d3d-4fe5-b6e7-d76e62892969 | 2024-08-15 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | 28fec572-e3b9-448c-8626-5c0920f38eeb | 2024-07-30 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | df6bb893-e3d7-4c8f-8cec-35b4d2fa33b3 | 2024-07-26 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | f4ced8c7-a276-4a44-a60c-f8d1689a2bdf | 2024-07-26 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | ada33464-b416-9ac6-e053-2a95a90af787 | 2024-07-17 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 90a76d24-e5a9-9000-e053-2a95a90ae8af | 2024-06-19 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 92be9844-0775-4808-bdeb-dccb09647d91 | 2024-03-07 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | 0edeb103-5e94-4f42-828f-c7336486c784 | 2024-02-15 | Warnings, Adverse reactions | 210221 ANDA210221 |
| Cephalexin | CEPHALEXIN | Ascend Laboratories, LLC | bb28751c-bd1b-4e7f-8271-a14c1b4314e3 | 2022-07-07 | Warnings, Adverse reactions | 210221 ANDA210221 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309113 | cephalexin 250 MG in 5 mL Oral Suspension | PSN | 9fc5cfb0-7ba0-4669-b79c-270b6a9ff573 | 1 |
| 309113 | cephalexin 50 MG/ML Oral Suspension | SCD | 9fc5cfb0-7ba0-4669-b79c-270b6a9ff573 | 1 |
| 309113 | cefalexin 50 MG/ML Oral Suspension | SY | 9fc5cfb0-7ba0-4669-b79c-270b6a9ff573 | 1 |
| 309113 | cephalexin 250 MG per 5 ML Oral Suspension | SY | 9fc5cfb0-7ba0-4669-b79c-270b6a9ff573 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-4511-0 | 70518451100 | 100 mL in 1 BOTTLE (70518-4511-0) | 100 ml | 2025-10-28 | No | No | Current |