amoxicillin and clavulanate potassium
- Product NDC
- 43598-208
- 11-digit product format
- 435980208
- Labeler code
- 43598
- Product ID
- 43598-208_4291f971-d386-411e-8d06-95be682a3961
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amoxicillin and clavulanate potassium
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc
- Application
- NDA050725
- Marketing category
- NDA
- Marketing start
- 1990-10-22
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 400 mg/5mL; mg/5mL
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 | 43598-208 | I | Inactivated by FDA | 2026-10-05 | ||
| excluded package | package | 43598-208 | 43598-208-50 | I | Inactivated by FDA | 2026-10-05 | |
| excluded package | package | 43598-208 | 43598-208-51 | I | Inactivated by FDA | 2026-10-05 | |
| excluded package | package | 43598-208 | 43598-208-52 | I | Inactivated by FDA | 2026-10-05 |
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 | 43598-208-51 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43598-208-50 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43598-208-52 | 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 | 43598-208-51 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43598-208-50 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 43598-208-52 | 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 | 43598-208-51 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43598-208-50 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 43598-208-52 | 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 | 43598-208-51 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43598-208-50 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 43598-208-52 | 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 | 43598-208-51 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43598-208-50 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 43598-208-52 | 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 | 43598-208-51 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43598-208-50 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 43598-208-52 | 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 | 43598-208-51 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43598-208-50 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 43598-208-52 | 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 | 43598-208-51 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 43598-208-50 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 43598-208-52 | 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 | 43598-208-51 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 43598-208-50 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 43598-208-52 | 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 | 43598-208-51 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 43598-208-50 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 43598-208-52 | 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 | 43598-208-51 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 43598-208-50 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 43598-208-52 | 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 | 43598-208-51 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 43598-208-50 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 43598-208-52 | 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 | 43598-208-51 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 43598-208-50 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 43598-208-52 | 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 | 43598-208-51 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 43598-208-50 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 43598-208-52 | 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 | 43598-208-51 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 43598-208-50 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 43598-208-52 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050725-001 | AUGMENTIN '200' | AMOXICILLIN; CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | |
| N050725-002 | AUGMENTIN '400' | AMOXICILLIN; CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050725-001 | AUGMENTIN '200' | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050725-002 | AUGMENTIN '400' | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1996-05-31 | 74a2ff9319b5… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 502415e5-4ac7-4266-a01a-ef44aa3c028d | Product name | 7 | 20250623 |
| d0f377c9-74d8-e2e3-e06e-4d37534f5c0f | Product name | 3 | 20250620 |
| 2ebbc361-d28f-48a9-a286-c1ae09cdaf5c | Product name | 3 | 20230314 |
| 2bb254ff-3d7f-4bdb-abf9-476506008c55 | Product name | 1 | 20230117 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| f33561b9-47cb-411c-a228-16c62e346cd4 | Product name | 1 | 20200415 |
| 8690a824-4bf8-4d1e-b118-2d6dda86bc04 | Product name | 2 | 20161206 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
| cf3f1c02-1f32-2322-3314-b70ebbf5610e | Product name | 1 | 20140508 |
| ebb3e917-326a-9e18-0354-a19c9f63a2f3 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43598-208-50 | amoxicillin and clavulanate potassium | 50 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 50 | 7 | |
| 43598-208-51 | amoxicillin and clavulanate potassium | 75 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 75 | 7 | |
| 43598-208-52 | amoxicillin and clavulanate potassium | 100 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 100 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43598-208-50 | ML - Milliliter | 43598-208 | 40513295-b245-4ec9-af60-19a7d57a2093 | 1 | 2012-07-24 |
| 43598-208-51 | ML - Milliliter | 43598-208 | f846cbbb-1f70-458a-bf6f-253f14c6ce07 | 1 | 2012-07-24 |
| 43598-208-52 | ML - Milliliter | 43598-208 | d6790a21-87b7-4279-ae69-d1b10f9bc882 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43598-208 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DR. REDDY'S LABORATORIES INC] | 7 | Legacy NDC, 3 package rows | 20160913_58a20183-4eb6-438e-bd1e-a74f4645bb0d.zip |
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 |
|---|---|---|---|---|---|---|
| amoxicillin and clavulanate potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Proficient Rx LP | 1f252ad3-373c-4a6d-96e7-53ba820d201b | 2019-11-01 | Warnings, Adverse reactions | 050725 NDA050725 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617423 | amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral Suspension | PSN | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 562251 | amoxicillin 250 MG / clavulanate potassium 125 MG Oral Tablet | PSN | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 617322 | amoxicillin 250 MG / clavulanic acid 62.5 MG in 5 mL Oral Suspension | PSN | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 617430 | amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral Suspension | PSN | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 617296 | amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet | PSN | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 562508 | amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet | PSN | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 562251 | amoxicillin 250 MG / clavulanate 125 MG Oral Tablet | SCD | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 617423 | amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral Suspension | SCD | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 617322 | amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral Suspension | SCD | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 617296 | amoxicillin 500 MG / clavulanate 125 MG Oral Tablet | SCD | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 617430 | amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral Suspension | SCD | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 562508 | amoxicillin 875 MG / clavulanate 125 MG Oral Tablet | SCD | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 617423 | amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral Suspension | SY | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 562251 | amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 617322 | amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 62.5 MG per 5 Oral Suspension | SY | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 617430 | amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral Suspension | SY | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 617296 | amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 562508 | amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 617423 | amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral Suspension | SY | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 617322 | amoxicillin 250 MG / clavulanic acid 62.5 MG per 5 ML Oral Suspension | SY | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 617430 | amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral Suspension | SY | 58a20183-4eb6-438e-bd1e-a74f4645bb0d | 7 |
| 617430 | amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral Suspension | PSN | 1f252ad3-373c-4a6d-96e7-53ba820d201b | 4 |
| 617430 | amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral Suspension | SCD | 1f252ad3-373c-4a6d-96e7-53ba820d201b | 4 |
| 617430 | amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral Suspension | SY | 1f252ad3-373c-4a6d-96e7-53ba820d201b | 4 |
| 617430 | amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral Suspension | SY | 1f252ad3-373c-4a6d-96e7-53ba820d201b | 4 |
| 617423 | amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral Suspension | PSN | cd60e48c-c6ce-4b30-8f82-5d9a3e5c0f51 | 2 |
| 617322 | amoxicillin 250 MG / clavulanic acid 62.5 MG in 5 mL Oral Suspension | PSN | cd60e48c-c6ce-4b30-8f82-5d9a3e5c0f51 | 2 |
| 617430 | amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral Suspension | PSN | cd60e48c-c6ce-4b30-8f82-5d9a3e5c0f51 | 2 |
| 617423 | amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral Suspension | SCD | cd60e48c-c6ce-4b30-8f82-5d9a3e5c0f51 | 2 |
| 617322 | amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral Suspension | SCD | cd60e48c-c6ce-4b30-8f82-5d9a3e5c0f51 | 2 |
| 617430 | amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral Suspension | SCD | cd60e48c-c6ce-4b30-8f82-5d9a3e5c0f51 | 2 |
| 617423 | amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral Suspension | SY | cd60e48c-c6ce-4b30-8f82-5d9a3e5c0f51 | 2 |
| 617322 | amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 62.5 MG per 5 Oral Suspension | SY | cd60e48c-c6ce-4b30-8f82-5d9a3e5c0f51 | 2 |
| 617430 | amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral Suspension | SY | cd60e48c-c6ce-4b30-8f82-5d9a3e5c0f51 | 2 |
| 617423 | amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral Suspension | SY | cd60e48c-c6ce-4b30-8f82-5d9a3e5c0f51 | 2 |
| 617322 | amoxicillin 250 MG / clavulanic acid 62.5 MG per 5 ML Oral Suspension | SY | cd60e48c-c6ce-4b30-8f82-5d9a3e5c0f51 | 2 |
| 617430 | amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral Suspension | SY | cd60e48c-c6ce-4b30-8f82-5d9a3e5c0f51 | 2 |
| 617430 | amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral Suspension | PSN | f0c660da-4198-4d04-87e9-5d6a7b6f75cf | 1 |
| 617430 | amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral Suspension | SCD | f0c660da-4198-4d04-87e9-5d6a7b6f75cf | 1 |
| 617430 | amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral Suspension | SY | f0c660da-4198-4d04-87e9-5d6a7b6f75cf | 1 |
| 617430 | amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral Suspension | SY | f0c660da-4198-4d04-87e9-5d6a7b6f75cf | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 43598-208-50 | 43598020850 | 50 mL in 1 BOTTLE | 50 ml | Historical |
| 43598-208-51 | 43598020851 | 75 mL in 1 BOTTLE | 75 ml | Historical |
| 43598-208-52 | 43598020852 | 100 mL in 1 BOTTLE | 100 ml | Historical |