Cephalexin
- Product NDC
- 10544-946
- 11-digit product format
- 105440946
- Labeler code
- 10544
- Product ID
- 10544-946_1ff373df-bc3c-70d8-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cephalexin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA062713
- Marketing category
- ANDA
- Marketing start
- 2015-09-15
- Marketing end
- 0000-00-00
- Substance
- CEPHALEXIN
- Active strength
- 250 mg/1
- 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 | 10544-946 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 10544-946 | 10544-946-08 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 10544-946 | 10544-946-21 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 10544-946 | 10544-946-28 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 10544-946 | 10544-946-30 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 10544-946 | 10544-946-40 | 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 | 10544-946-40 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 10544-946-28 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 10544-946-08 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 10544-946-21 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 10544-946-30 | 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 | 10544-946-40 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 10544-946-28 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 10544-946-08 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 10544-946-21 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 10544-946-30 | 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 | 10544-946-40 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 10544-946-28 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 10544-946-08 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 10544-946-21 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 10544-946-30 | 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 | 10544-946-40 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 10544-946-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 10544-946-08 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 10544-946-21 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 10544-946-30 | 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 | 10544-946-40 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 10544-946-28 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 10544-946-08 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 10544-946-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 10544-946-30 | 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 | 10544-946-40 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 10544-946-28 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 10544-946-08 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 10544-946-21 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 10544-946-30 | 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 | 10544-946-40 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 10544-946-28 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 10544-946-08 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 10544-946-21 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 10544-946-30 | 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 | 10544-946-40 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 10544-946-28 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 10544-946-08 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 10544-946-21 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 10544-946-30 | 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 | 10544-946-40 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 10544-946-28 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 10544-946-08 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 10544-946-21 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 10544-946-30 | 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 | 10544-946-40 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 10544-946-28 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 10544-946-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 10544-946-21 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 10544-946-30 | ad56d346431e… | cc804d4bbf1e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062713-001 | CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | |
| A062713-002 | CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A062713-001 | AB |
| A062713-002 | 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 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A062713-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A062713-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 1988-07-15 | 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 | A062713-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A062713-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A062713-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A062713-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062713-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062713-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A062713-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A062713-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062713-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062713-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062713-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062713-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062713-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062713-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062713-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062713-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062713-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062713-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062713-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062713-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A062713-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A062713-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062713-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062713-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062713-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062713-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062713-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062713-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A062713-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A062713-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062713-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062713-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A062713-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A062713-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A062713-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A062713-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A062713-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A062713-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A062713-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A062713-002 | 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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10544-946-08 | Cephalexin | 8 in 1 BOTTLE | CAPSULE | 8 | 2 | |
| 10544-946-21 | Cephalexin | 21 in 1 BOTTLE | CAPSULE | 21 | 2 | |
| 10544-946-28 | Cephalexin | 28 in 1 BOTTLE | CAPSULE | 28 | 2 | |
| 10544-946-30 | Cephalexin | 30 in 1 BOTTLE | CAPSULE | 30 | 2 | |
| 10544-946-40 | Cephalexin | 40 in 1 BOTTLE | CAPSULE | 40 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10544-946-08 | EA - Each | 10544-946 | 8f753fd7-3ba3-47c0-9a9a-56ff8bc58827 | 1 | 2016-01-13 |
| 10544-946-21 | EA - Each | 10544-946 | cf930b8e-ed01-4bf6-8c35-9f4466e79a04 | 1 | 2016-01-13 |
| 10544-946-28 | EA - Each | 10544-946 | a67251b5-5c3c-4b41-a4de-349b804caf65 | 1 | 2016-01-13 |
| 10544-946-30 | EA - Each | 10544-946 | c355c0a4-b1cd-437b-b96a-cf4f7a2c8e5e | 1 | 2016-01-13 |
| 10544-946-40 | EA - Each | 10544-946 | 6c771a69-a8fb-490d-9adc-0320028b7152 | 1 | 2016-01-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CEPHALEXIN | ACTIVE INGREDIENT | OBN7UDS42Y | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 2 | |
| CEPHALEXIN ANHYDROUS | ACTIVE MOIETY | 5SFF1W6677 | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 2 |
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 | AvKARE | 03f6f6ae-66bc-6819-8ba9-7c9c3fbef90d | 2026-07-29 | Warnings, Adverse reactions | 062713 ANDA062713 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309112 | cephalexin 250 MG Oral Capsule | PSN | 1fcb287b-618f-67cc-e054-00144ff88e88 | 2 |
| 309114 | cephalexin 500 MG Oral Capsule | PSN | 1fcb287b-618f-67cc-e054-00144ff88e88 | 2 |
| 309112 | cephalexin 250 MG Oral Capsule | SCD | 1fcb287b-618f-67cc-e054-00144ff88e88 | 2 |
| 309114 | cephalexin 500 MG Oral Capsule | SCD | 1fcb287b-618f-67cc-e054-00144ff88e88 | 2 |
| 309114 | cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule | SY | 1fcb287b-618f-67cc-e054-00144ff88e88 | 2 |
| 309112 | cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule | SY | 1fcb287b-618f-67cc-e054-00144ff88e88 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 10544-946-08 | 10544094608 | 8 in 1 BOTTLE | Historical |
| 10544-946-21 | 10544094621 | 21 in 1 BOTTLE | Historical |
| 10544-946-28 | 10544094628 | 28 in 1 BOTTLE | Historical |
| 10544-946-30 | 10544094630 | 30 in 1 BOTTLE | Historical |
| 10544-946-40 | 10544094640 | 40 in 1 BOTTLE | Historical |