CEFACLOR
- Product NDC
- 43063-194
- 11-digit product format
- 430630194
- Labeler code
- 43063
- Product ID
- 43063-194_7cc49c7e-4408-39f7-e053-2a91aa0aab5c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CEFACLOR
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA065350
- Marketing category
- ANDA
- Marketing start
- 2007-05-01
- Marketing end
- 0000-00-00
- Substance
- CEFACLOR
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 43063-194 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 43063-194 | 43063-194-30 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A065350-001 | CEFACLOR | CEFACLOR | EQ 250MG BASE | CAPSULE / ORAL | | | 2007-04-03 |
| A065350-002 | CEFACLOR | CEFACLOR | EQ 500MG BASE | CAPSULE / ORAL | | | 2007-04-03 |