Cefuroxime Axetil
- Product NDC
- 70934-088
- 11-digit product format
- 709340088
- Labeler code
- 70934
- Product ID
- 70934-088_b816218e-39fd-3c71-e053-2995a90a9306
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefuroxime Axetil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Application
- ANDA065308
- Marketing category
- ANDA
- Marketing start
- 2018-03-20
- Marketing end
- 0000-00-00
- Substance
- CEFUROXIME AXETIL
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70934-088 | I | Inactivated by FDA | 2026-07-31 | ||
| excluded package | package | 70934-088 | 70934-088-20 | I | Inactivated by FDA | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065308-001 | CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 125MG BASE | TABLET / ORAL | AB | 2006-03-29 | |
| A065308-002 | CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2006-03-29 | |
| A065308-003 | CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2006-03-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065308-001 | AB |
| A065308-002 | AB |
| A065308-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A065308-001 | CEFUROXIME AXETIL | EQ 125MG BASE | TABLET / ORAL | AB | 2006-03-29 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A065308-002 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2006-03-29 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A065308-003 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2006-03-29 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A065308-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A065308-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A065308-003 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cefuroxime Axetil | CEFUROXIME AXETIL | Redpharm Drug | 56cb6f42-9ae1-38e7-e063-6294a90a3feb | 2026-07-17 | Warnings, Adverse reactions | 065308 ANDA065308 |
| Cefuroxime Axetil | CEFUROXIME AXETIL | A-S Medication Solutions | 85cdd8d9-557e-4d15-855a-027e7809cf64 | 2026-05-14 | Warnings, Adverse reactions | 065308 ANDA065308 |
| Cefuroxime Axetil | CEFUROXIME AXETIL | A-S Medication Solutions | d14d4184-3e29-43cd-8046-658699c70f03 | 2026-05-14 | Warnings, Adverse reactions | 065308 ANDA065308 |
| Cefuroxime Axetil | CEFUROXIME AXETIL | PD-Rx Pharmaceuticals, Inc. | a84ac4ed-c268-4e9f-9df8-256e0a64cd16 | 2026-03-18 | Warnings, Adverse reactions | 065308 ANDA065308 |
| Cefuroxime Axetil | CEFUROXIME AXETIL | REMEDYREPACK INC. | 76cec54f-d167-4298-951b-5411a3c47f4a | 2026-02-13 | Warnings, Adverse reactions | 065308 ANDA065308 |
| Cefuroxime Axetil | CEFUROXIME AXETIL | A-S Medication Solutions | a940ba01-2b53-4947-9019-d3d8f4e9ad80 | 2026-01-23 | Warnings, Adverse reactions | 065308 ANDA065308 |
| Cefuroxime Axetil | CEFUROXIME AXETIL | A-S Medication Solutions | aa6685c1-51ed-466a-ae7f-89a82986a7b1 | 2025-10-08 | Warnings, Adverse reactions | 065308 ANDA065308 |
| Cefuroxime Axetil | CEFUROXIME AXETIL | A-S Medication Solutions | 119c4d09-2324-498f-9318-1f8db49ad4b6 | 2025-10-08 | Warnings, Adverse reactions | 065308 ANDA065308 |
| Cefuroxime Axetil | CEFUROXIME AXETIL | NuCare Pharmaceuticals, Inc. | 3f92c452-18b4-5af8-e063-6394a90aaa53 | 2025-09-24 | Warnings, Adverse reactions | 065308 ANDA065308 |
| Cefuroxime Axetil | CEFUROXIME AXETIL | Preferred Pharmaceuticals Inc. | bc9200d2-4a6d-4847-ba85-8e9d378390de | 2025-07-31 | Warnings, Adverse reactions | 065308 ANDA065308 |
| Cefuroxime Axetil | CEFUROXIME AXETIL | Coupler LLC | 2c619a79-6b69-b9fa-e063-6394a90a8f27 | 2025-01-23 | Warnings, Adverse reactions | 065308 ANDA065308 |
| Cefuroxime Axetil | CEFUROXIME AXETIL | Coupler LLC | 2c3a502f-8e72-c4d2-e063-6394a90a6fa5 | 2025-01-21 | Warnings, Adverse reactions | 065308 ANDA065308 |
| Cefuroxime Axetil | CEFUROXIME AXETIL | NorthStar Rx LLC | fd79c41e-b0e9-47dc-a3ce-caacdc66bc96 | 2024-04-30 | Warnings, Adverse reactions | 065308 ANDA065308 |
| Cefuroxime Axetil | CEFUROXIME AXETIL | Aurobindo Pharma Limited | faef39e9-d793-4191-a728-310f6fab759d | 2024-04-29 | Warnings, Adverse reactions | 065308 ANDA065308 |
| Cefuroxime Axetil | CEFUROXIME AXETIL | Rising Pharma Holdings, Inc. | 66f8d37f-aebc-4435-af80-dfd7b3770088 | 2024-04-29 | Warnings, Adverse reactions | 065308 ANDA065308 |
| Cefuroxime Axetil | CEFUROXIME AXETIL | A-S Medication Solutions | eb180b38-f8c8-4dbf-856a-347d3ebac857 | 2024-02-27 | Warnings, Adverse reactions | 065308 ANDA065308 |
| Cefuroxime Axetil | CEFUROXIME AXETIL | A-S Medication Solutions | bcf7870a-7e45-4ae1-a9b4-457e4781886a | 2024-01-04 | Warnings, Adverse reactions | 065308 ANDA065308 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba66f2a7-7ba5-e81a-8863-a38bd5c2e969 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70934-088-20 | 2023-01-30 | C162847 | 48780-1 | f386c649-d3b1-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use CEFUROXIME AXETIL TABLETS safely and effectively. See full prescribing information for CEFUROXIME AXETIL TABLETS. CEFUROXIME AXETIL tablets, for oral use Initial U.S. Approval: 1987 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70934-088-20 | Cefuroxime Axetil | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70934-088-20 | EA - Each | 70934-088 | 98115a70-cd98-4245-a25f-ed27db3dc409 | 1 | 2018-05-09 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309098 | cefuroxime axetil 500 MG Oral Tablet | PSN | 697ee167-b015-7534-e053-2a91aa0ace3f | 3 |
| 309098 | cefuroxime 500 MG Oral Tablet | SCD | 697ee167-b015-7534-e053-2a91aa0ace3f | 3 |
| 309098 | cefuroxime (as cefuroxime axetil) 500 MG Oral Tablet | SY | 697ee167-b015-7534-e053-2a91aa0ace3f | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70934-088-20 | 70934008820 | 20 TABLET in 1 BOTTLE, PLASTIC (70934-088-20) | 20 tablet | 2018-03-20 | 0000-00-00 | No | No | Current |