Cefuroxime axetil
- Product NDC
- 50090-2159
- 11-digit product format
- 500902159
- Labeler code
- 50090
- Product ID
- 50090-2159_16361438-6bf9-42ee-93e0-1cda506d9bd3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefuroxime axetil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA065496
- Marketing category
- ANDA
- Marketing start
- 2010-12-01
- Substance
- CEFUROXIME AXETIL
- Active strength
- 250 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065496-001 | CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | |
| A065496-002 | CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065496-001 | AB |
| A065496-002 | 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 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065496-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2010-06-07 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065496-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | 2010-06-07 | 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 | A065496-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A065496-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A065496-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065496-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065496-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065496-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065496-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065496-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065496-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065496-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065496-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065496-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065496-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065496-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065496-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065496-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065496-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065496-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065496-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065496-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065496-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065496-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065496-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065496-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065496-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065496-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065496-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065496-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065496-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065496-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065496-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065496-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065496-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065496-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065496-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065496-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065496-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065496-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065496-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065496-002 | AB | 1 | bb7c543d1eb4… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cefuroxime axetil
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CEFUROXIME AXETIL | 250 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| Z49QDT0J8Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 309097 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 84593261-838c-433a-8d9d-1d37b11058da | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba66f2a7-7ba5-e81a-8863-a38bd5c2e969 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-2159-0 | Cefuroxime axetil | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 17 | |
| 50090-2159-1 | Cefuroxime axetil | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-2159-0 | EA - Each | 50090-2159 | f4d63fcb-70fb-436f-a5a9-c617e939008f | 1 | 2019-02-13 |
| 50090-2159-1 | EA - Each | 50090-2159 | e40d5dc7-98e2-4654-831e-294d6ad2171a | 1 | 2024-10-04 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-2159 | CEFUROXIME AXETIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 17 | Current NDC, Legacy NDC, 2 package rows | 20240912_84593261-838c-433a-8d9d-1d37b11058da.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 |
|---|---|---|---|---|---|---|
| Cefuroxime axetil | CEFUROXIME AXETIL | Golden State Medical Supply, Inc. | bb7955fe-5111-1662-e053-2a95a90a85a1 | 2026-04-23 | Warnings, Adverse reactions | 065496 ANDA065496 |
| Cefuroxime axetil | CEFUROXIME AXETIL | NuCare Pharmaceuticals, Inc. | 4e4426a4-0ca9-dad5-e063-6294a90a5fdb | 2026-03-30 | Warnings, Adverse reactions | 065496 ANDA065496 |
| Cefuroxime axetil | CEFUROXIME AXETIL | Advanced Rx of Tennessee, LLC | 48d96608-d3da-b512-e063-6294a90a07d5 | 2026-01-16 | Warnings, Adverse reactions | 065496 ANDA065496 |
| Cefuroxime axetil | CEFUROXIME AXETIL | Redpharm Drug | 3744f28c-c7e1-259c-e063-6294a90a10ed | 2025-12-11 | Warnings, Adverse reactions | 065496 ANDA065496 |
| Cefuroxime axetil | CEFUROXIME AXETIL | PD-Rx Pharmaceuticals, Inc. | 2af8f061-c0e1-3a1c-e054-00144ff8d46c | 2025-10-15 | Warnings, Adverse reactions | 065496 ANDA065496 |
| Cefuroxime axetil | CEFUROXIME AXETIL | PD-Rx Pharmaceuticals, Inc. | 2af94304-8118-41c7-e054-00144ff8d46c | 2025-10-15 | Warnings, Adverse reactions | 065496 ANDA065496 |
| Cefuroxime axetil | CEFUROXIME AXETIL | Ascend Laboratories, LLC | dd11e4b9-7730-4d3a-81ca-16f15de09759 | 2025-10-03 | Warnings, Adverse reactions | 065496 ANDA065496 |
| Cefuroxime axetil | CEFUROXIME AXETIL | Major Pharmaceuticals | 44e1fb4d-4b61-40da-9974-0bd2006eb828 | 2025-09-12 | Warnings, Adverse reactions | 065496 ANDA065496 |
| Cefuroxime axetil | CEFUROXIME AXETIL | American Health Packaging | f38418a7-dd90-4f20-b747-7ac086c53015 | 2025-08-06 | Warnings, Adverse reactions | 065496 ANDA065496 |
| Cefuroxime axetil | CEFUROXIME AXETIL | PD-Rx Pharmaceuticals, Inc. | 15cabe73-f39d-4798-a840-115fe94f8f96 | 2025-03-13 | Warnings, Adverse reactions | 065496 ANDA065496 |
| Cefuroxime axetil | CEFUROXIME AXETIL | A-S Medication Solutions | 84593261-838c-433a-8d9d-1d37b11058da | 2024-09-11 | Warnings, Adverse reactions | 065496 ANDA065496 50090-2159 |
| Cefuroxime axetil | CEFUROXIME AXETIL | NuCare Pharmaceuticals,Inc. | 83476d51-be74-748b-e053-2a91aa0a3d36 | 2024-07-15 | Warnings, Adverse reactions | 065496 ANDA065496 |
| Cefuroxime axetil | CEFUROXIME AXETIL | NuCare Pharmaceuticals,Inc. | 8c3c1c85-cbce-66e2-e053-2a95a90a94fe | 2024-06-18 | Warnings, Adverse reactions | 065496 ANDA065496 |
| Cefuroxime axetil | CEFUROXIME AXETIL | A-S Medication Solutions | c89e8f4d-96c0-44c6-906a-b803141920b1 | 2024-02-13 | Warnings, Adverse reactions | 065496 ANDA065496 |
| Cefuroxime axetil | CEFUROXIME AXETIL | Proficient Rx LP | e9a020ec-e446-469a-b1d1-07e82eefa305 | 2023-07-01 | Warnings, Adverse reactions | 065496 ANDA065496 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309097 | cefuroxime axetil 250 MG Oral Tablet | PSN | 84593261-838c-433a-8d9d-1d37b11058da | 17 |
| 309097 | cefuroxime 250 MG Oral Tablet | SCD | 84593261-838c-433a-8d9d-1d37b11058da | 17 |
| 309097 | cefuroxime (as cefuroxime axetil) 250 MG Oral Tablet | SY | 84593261-838c-433a-8d9d-1d37b11058da | 17 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-2159-0 | 50090215900 | 20 TABLET, FILM COATED in 1 BOTTLE (50090-2159-0) | 2015-10-21 | 0000-00-00 | No | No | Current |
| 50090-2159-1 | 50090215901 | 14 TABLET, FILM COATED in 1 BOTTLE (50090-2159-1) | 2024-08-26 | No | No | Current |