Application 065229
- Type
- ANDA
- Sponsor
- LUPIN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEPHALEXIN | CEPHALEXIN | CAPSULE;ORAL | EQ 250MG BASE | No | No |
| 002 | CEPHALEXIN | CEPHALEXIN | CAPSULE;ORAL | EQ 500MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065229-001 | CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | |
| A065229-002 | CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065229-001 | AB |
| A065229-002 | 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 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065229-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065229-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2005-11-25 | 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 | A065229-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065229-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065229-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065229-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065229-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065229-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065229-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065229-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065229-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065229-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065229-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065229-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065229-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065229-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065229-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065229-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065229-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065229-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065229-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065229-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065229-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065229-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065229-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065229-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065229-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065229-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065229-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065229-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065229-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065229-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065229-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065229-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065229-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065229-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065229-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065229-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065229-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065229-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065229-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A065229-002 | AB | 1 | 782e0a99824c… |
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 | REMEDYREPACK INC. | b3bb8222-161e-4d9c-8e08-7e22ad65bf72 | 2026-06-16 | Warnings, Adverse reactions | 065229 ANDA065229 70518-3448 |
| Cephalexin | CEPHALEXIN | REMEDYREPACK INC. | 8499aa5a-49b1-4555-bd27-6177d92b261d | 2026-06-09 | Warnings, Adverse reactions | 065229 ANDA065229 |
| Cephalexin | CEPHALEXIN | Coupler LLC | 508a3401-df0b-0555-e063-6294a90a155a | 2026-04-28 | Warnings, Adverse reactions | 065229 ANDA065229 |
| Cephalexin | CEPHALEXIN | Sportpharm LLC | 3d5a2665-65da-4b10-9e23-39fc88145da1 | 2026-02-03 | Warnings, Adverse reactions | 065229 ANDA065229 |
| Cephalexin | CEPHALEXIN | Asclemed USA, Inc. | 13444dc7-7da1-4181-a9ac-d95d4a235e6d | 2025-12-10 | Warnings, Adverse reactions | 065229 ANDA065229 76420-052 |
| Cephalexin | CEPHALEXIN | Lupin Pharmaceuticals, Inc. | 1d3e6d33-5dc2-498e-8efa-e3c4fca15dff | 2025-10-15 | Warnings, Adverse reactions | 065229 ANDA065229 68180-122 68180-121 |
| Cephalexin | CEPHALEXIN | ADVANCED RX PHARMACY OF TENNESSEE, LLC | af4abf8b-22cc-da58-e053-2a95a90aa766 | 2024-12-31 | Warnings, Adverse reactions | 065229 ANDA065229 80425-0006 |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | a33280d4-7caf-f74b-e053-2a95a90a90c3 | 2024-07-17 | Warnings, Adverse reactions | 065229 ANDA065229 68071-5241 |
| Cephalexin | CEPHALEXIN | Asclemed USA, Inc | 945552cb-90e4-41fb-afe2-8ee8785e94da | 2024-07-17 | Warnings, Adverse reactions | 065229 ANDA065229 |
| Cephalexin | CEPHALEXIN | Asclemed USA, Inc. | 20f8cc57-231c-4d36-a209-ff9e5735d65c | 2024-06-20 | Warnings, Adverse reactions | 065229 ANDA065229 |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e | 2024-06-10 | Warnings, Adverse reactions | 065229 ANDA065229 68071-4406 |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 728c5212-dbd8-8df5-e053-2a91aa0a9579 | 2024-06-10 | Warnings, Adverse reactions | 065229 ANDA065229 68071-4516 |
| Cephalexin | CEPHALEXIN | ADVANCED RX PHARMACY OF TENNESSEE, LLC | af10128f-021a-14b7-e053-2a95a90a4365 | 2024-01-18 | Warnings, Adverse reactions | 065229 ANDA065229 80425-0005 |
| Cephalexin | CEPHALEXIN | Asclemed USA, Inc. | 6032b68f-16d8-41b6-bd2c-86d5406a757a | 2022-09-21 | Warnings, Adverse reactions | 065229 ANDA065229 76420-287 76420-288 |
| Cephalexin | CEPHALEXIN | Proficient Rx LP | dec3a1ef-1e85-4236-804b-e7a343d3a58f | 2022-05-02 | Warnings, Adverse reactions | 065229 ANDA065229 63187-046 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10544-013 | Cephalexin | Cephalexin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-021 | Cephalexin | Cephalexin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 50090-0072 | Cephalexin | Cephalexin | A-S Medication Solutions | ANDA | Current |
| 50090-0073 | Cephalexin | Cephalexin | A-S Medication Solutions | ANDA | Current |
| 50090-3052 | Cephalexin | Cephalexin | A-S Medication Solutions | ANDA | Current |
| 50090-3052 | Cephalexin | Cephalexin | A-S Medication Solutions | ANDA | Current |
| 50090-3057 | Cephalexin | Cephalexin | A-S Medication Solutions | ANDA | Current |
| 50090-3057 | Cephalexin | Cephalexin | A-S Medication Solutions | ANDA | Current |
| 50090-3111 | Cephalexin | Cephalexin | A-S Medication Solutions | ANDA | Current |
| 50090-3111 | Cephalexin | Cephalexin | A-S Medication Solutions | ANDA | Current |
| 50436-2210 | Cephalexin | Cephalexin | Unit Dose Services | ANDA | Current |
| 51655-125 | Cephalexin | Cephalexin | Northwind Pharmaceuticals | ANDA | Current |
| 52959-030 | Cephalexin | Cephalexin | H.J. Harkins Company, Inc. | ANDA | Current |
| 53002-2180 | Cephalexin | Cephalexin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2180 | Cephalexin | Cephalexin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2260 | Cephalexin | Cephalexin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2260 | Cephalexin | Cephalexin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53808-0939 | Cephalexin | Cephalexin | State of Florida DOH Central Pharmacy | ANDA | Current |
| 54348-560 | Cephalexin | CEPHALEXIN | PharmPak, Inc. | ANDA | Current |
| 54348-560 | Cephalexin | CEPHALEXIN | PharmPak, Inc. | ANDA | Current |
| 55700-533 | Cephalexin | Cephalexin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 57297-121 | Cephalexin | Cephalexin | LUPIN LIMITED | ANDA | Current |
| 57297-122 | Cephalexin | Cephalexin | LUPIN LIMITED | ANDA | Current |
| 63187-046 | Cephalexin | Cephalexin | Proficient Rx LP | ANDA | Current |
| 63187-046 | Cephalexin | Cephalexin | Proficient Rx LP | ANDA | Current |
| 63187-046 | Cephalexin | Cephalexin | Proficient Rx LP | ANDA | Current |
| 63187-046 | Cephalexin | Cephalexin | Proficient Rx LP | ANDA | Current |
| 63629-1317 | Cephalexin | Cephalexin | Bryant Ranch Prepack | ANDA | Current |
| 64725-0121 | Cephalexin | Cephalexin | TYA Pharmaceuticals | ANDA | Current |
| 67296-0320 | Cephalexin | Cephalexin | RedPharm Drug Inc. | ANDA | Current |
| 68071-4342 | Cephalexin | Cephalexin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4406 | Cephalexin | Cephalexin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4406 | Cephalexin | Cephalexin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4406 | Cephalexin | Cephalexin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4516 | Cephalexin | Cephalexin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4516 | Cephalexin | Cephalexin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4516 | Cephalexin | Cephalexin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5241 | Cephalexin | Cephalexin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5241 | Cephalexin | Cephalexin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68180-121 | Cephalexin | Cephalexin | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-121 | Cephalexin | Cephalexin | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-122 | Cephalexin | Cephalexin | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-122 | Cephalexin | Cephalexin | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7761 | Cephalexin | Cephalexin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7761 | Cephalexin | Cephalexin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7761 | Cephalexin | Cephalexin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-1428 | Cephalexin | Cephalexin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1428 | Cephalexin | Cephalexin | REMEDYREPACK INC. | ANDA | Current |
| 70518-3448 | Cephalexin | Cephalexin | REMEDYREPACK INC. | ANDA | Current |
| 70518-3448 | Cephalexin | Cephalexin | REMEDYREPACK INC. | ANDA | Current |
| 70934-065 | Cephalexin | Cephalexin | Denton Pharma, Inc. | ANDA | Current |
| 70934-065 | Cephalexin | Cephalexin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-065 | Cephalexin | Cephalexin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-065 | Cephalexin | Cephalexin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-065 | Cephalexin | Cephalexin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-082 | Cephalexin | Cephalexin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-082 | Cephalexin | Cephalexin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-082 | Cephalexin | Cephalexin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-082 | Cephalexin | Cephalexin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 76420-052 | Cephalexin | Cephalexin | Asclemed USA, Inc. | ANDA | Current |
| 76420-287 | Cephalexin | Cephalexin | Asclemed USA, Inc. | ANDA | Current |
| 76420-288 | Cephalexin | Cephalexin | Asclemed USA, Inc. | ANDA | Current |
| 80425-0005 | Keflex | Cephalexin 500mg | ADVANCED RX PHARMACY OF TENNESSEE, LLC | ANDA | Current |
| 80425-0005 | Cephalexin | Cephalexin | ADVANCED RX PHARMACY OF TENNESSEE, LLC | ANDA | Current |
| 80425-0005 | Cephalexin | Cephalexin | ADVANCED RX PHARMACY OF TENNESSEE, LLC | ANDA | Current |
| 80425-0005 | Cephalexin | Cephalexin | ADVANCED RX PHARMACY OF TENNESSEE, LLC | ANDA | Current |
| 80425-0006 | Keflex | Cephalexin 500mg | ADVANCED RX PHARMACY OF TENNESSEE, LLC | ANDA | Current |
| 80425-0006 | Cephalexin | Cephalexin | ADVANCED RX PHARMACY OF TENNESSEE, LLC | ANDA | Current |
| 80425-0006 | Cephalexin | Cephalexin | ADVANCED RX PHARMACY OF TENNESSEE, LLC | ANDA | Current |
| 80425-0006 | Cephalexin | Cephalexin | ADVANCED RX PHARMACY OF TENNESSEE, LLC | ANDA | Current |