Cephalexin
- Product NDC
- 52959-620
- 11-digit product format
- 529590620
- Labeler code
- 52959
- Product ID
- 52959-620_2d3e1047-9978-4400-a4bd-76aff63420a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cephalexin
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA065234
- Marketing category
- ANDA
- Marketing start
- 2005-08-01
- Marketing end
- 0000-00-00
- Substance
- CEPHALEXIN
- Active strength
- 250 mg/5mL
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 product | product | 52959-620 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 52959-620 | 52959-620-00 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 52959-620 | 52959-620-01 | I | Inactivated by FDA | 2026-08-17 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-620-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-620-00 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-620-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-620-00 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-620-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-620-00 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52959-620-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52959-620-00 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52959-620-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52959-620-00 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52959-620-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52959-620-00 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52959-620-01 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52959-620-00 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52959-620-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52959-620-00 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52959-620-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52959-620-00 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 52959-620-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 52959-620-00 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 52959-620-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 52959-620-00 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 52959-620-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 52959-620-00 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 52959-620-01 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 52959-620-00 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 52959-620-01 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 52959-620-00 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 52959-620-01 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 52959-620-00 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 52959-620-01 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 52959-620-00 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 52959-620-01 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 52959-620-00 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 52959-620-01 | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 52959-620-00 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 52959-620-01 | 8dfbde2a14a4… | c9ff85d89658… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 52959-620-00 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 52959-620-01 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 52959-620-00 | e2bbac7714bc… | 27bdfed8d636… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065234-001 | CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | |
| A065234-002 | CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065234-001 | AB |
| A065234-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065234-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065234-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2005-08-17 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A065234-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A065234-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A065234-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065234-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065234-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065234-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065234-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065234-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065234-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065234-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065234-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065234-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065234-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065234-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065234-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065234-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065234-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065234-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065234-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065234-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065234-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065234-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065234-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065234-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065234-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065234-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065234-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065234-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065234-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065234-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065234-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065234-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065234-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065234-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065234-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065234-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065234-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065234-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065234-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065234-002 | AB | 1 | bb7c543d1eb4… |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52959-620-00 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c629-f6ea-e053-dbdaa90aa703 | CEPHALEXIN FOR ORAL SUSPENSION USP |
| 52959-620-01 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c629-f6ea-e053-dbdaa90aa703 | CEPHALEXIN FOR ORAL SUSPENSION USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52959-620-00 | Cephalexin | 100 mL in 1 BOTTLE | FOR SUSPENSION | 100 | 1 | |
| 52959-620-01 | Cephalexin | 200 mL in 1 BOTTLE | FOR SUSPENSION | 200 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52959-620-00 | ML - Milliliter | 52959-620 | e572ad31-ad44-4fa7-a607-cefc71515e13 | 1 | 2012-07-24 |
| 52959-620-01 | ML - Milliliter | 52959-620 | 41d2200c-86f1-40bf-9430-a7ba331428db | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CEPHALEXIN | ACTIVE INGREDIENT | OBN7UDS42Y | CEPHALEXIN (CEPHALEXIN ) FOR SUSPENSION [H.J. HARKINS COMPANY, INC.] | 1 | |
| CEPHALEXIN ANHYDROUS | ACTIVE MOIETY | 5SFF1W6677 | CEPHALEXIN (CEPHALEXIN ) FOR SUSPENSION [H.J. HARKINS COMPANY, INC.] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CEPHALEXIN (CEPHALEXIN ) FOR SUSPENSION [H.J. HARKINS COMPANY, INC.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | CEPHALEXIN (CEPHALEXIN ) FOR SUSPENSION [H.J. HARKINS COMPANY, INC.] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | CEPHALEXIN (CEPHALEXIN ) FOR SUSPENSION [H.J. HARKINS COMPANY, INC.] | 1 | |
| STRAWBERRY | INACTIVE INGREDIENT | 4J2TY8Y81V | CEPHALEXIN (CEPHALEXIN ) FOR SUSPENSION [H.J. HARKINS COMPANY, INC.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CEPHALEXIN (CEPHALEXIN ) FOR SUSPENSION [H.J. HARKINS COMPANY, INC.] | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | CEPHALEXIN (CEPHALEXIN ) FOR SUSPENSION [H.J. HARKINS COMPANY, INC.] | 1 |
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 |
|---|---|---|---|---|---|---|
| cephalexin | CEPHALEXIN | Lupin Pharmaceuticals, Inc. | 25ef498a-7a7e-4543-a544-b9d0e99f9cd9 | 2026-06-01 | Warnings, Adverse reactions | 065234 ANDA065234 |
| cephalexin | CEPHALEXIN | Preferred Pharmaceuticals Inc. | 553485f8-890d-4929-a6bb-905221cf411d | 2026-03-25 | Warnings, Adverse reactions | 065234 ANDA065234 |
| cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 141bd050-5dfc-68fa-e063-6394a90a6d86 | 2024-03-20 | Warnings, Adverse reactions | 065234 ANDA065234 |
| cephalexin | CEPHALEXIN | A-S Medication Solutions | d31da5be-c939-4aa0-adb8-b26a1396b228 | 2024-02-22 | Warnings, Adverse reactions | 065234 ANDA065234 |
| cephalexin | CEPHALEXIN | Proficient Rx LP | 829244bd-93da-4a5a-a257-890cfec4c06d | 2023-12-01 | Warnings, Adverse reactions | 065234 ANDA065234 |
| cephalexin | CEPHALEXIN | A-S Medication Solutions | 0a24b6e5-6f13-44b4-93f4-47c86945cad2 | 2023-04-26 | Warnings, Adverse reactions | 065234 ANDA065234 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309113 | cephalexin 250 MG in 5 mL Oral Suspension | PSN | 9a75fb7c-c249-4885-8a8f-78678b537452 | 1 |
| 309113 | cephalexin 50 MG/ML Oral Suspension | SCD | 9a75fb7c-c249-4885-8a8f-78678b537452 | 1 |
| 309113 | cefalexin 50 MG/ML Oral Suspension | SY | 9a75fb7c-c249-4885-8a8f-78678b537452 | 1 |
| 309113 | cephalexin 250 MG per 5 ML Oral Suspension | SY | 9a75fb7c-c249-4885-8a8f-78678b537452 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 52959-620-00 | 52959062000 | 100 mL in 1 BOTTLE | 100 ml | Historical |
| 52959-620-01 | 52959062001 | 200 mL in 1 BOTTLE | 200 ml | Historical |