Cefaclor
- Product NDC
- 63629-1007
- Requested package NDC
- 63629-1007-3
- 11-digit product format
- 636291007
- Labeler code
- 63629
- Product ID
- 63629-1007_42d6e553-875b-4c77-a161-3bb02c1f23b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefaclor
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA065146
- Marketing category
- ANDA
- Marketing start
- 2008-07-31
- Marketing end
- 0000-00-00
- Substance
- CEFACLOR
- Active strength
- 250 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 package | package | 63629-1007 | 63629-1007-3 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065146-001 | CEFACLOR | CEFACLOR | EQ 250MG BASE | CAPSULE / ORAL | 2004-01-22 | ||
| A065146-002 | CEFACLOR | CEFACLOR | EQ 500MG BASE | CAPSULE / ORAL | RS | 2004-01-22 |
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 | A065146-001 | CEFACLOR | EQ 250MG BASE | CAPSULE / ORAL | 2004-01-22 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | A065146-002 | CEFACLOR | EQ 500MG BASE | CAPSULE / ORAL | RS | 2004-01-22 | 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 |
|---|---|---|---|---|---|---|
| Cefaclor | CEFACLOR | Carlsbad Technology, Inc. | 2f61354e-bcb0-41aa-955f-51eabc11387b | 2025-05-01 | Warnings, Adverse reactions | 065146 ANDA065146 |
| Cefaclor | CEFACLOR | A-S Medication Solutions | d79a4b28-ef2b-4f0f-baec-002df7d06dd4 | 2024-01-31 | Warnings, Adverse reactions | 065146 ANDA065146 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-1007-3 | 63629100703 | 30 CAPSULE in 1 BOTTLE (63629-1007-3) | 30 capsule | 2022-04-14 | 0000-00-00 | No | No | Current |