Cefdinir
- Product NDC
- 53002-1526
- 11-digit product format
- 530021526
- Labeler code
- 53002
- Product ID
- 53002-1526_7e4ab69e-495d-4b51-bb1f-4f92b46b6d2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefdinir
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA065434
- Marketing category
- ANDA
- Marketing start
- 2008-01-07
- Marketing end
- 0000-00-00
- Substance
- CEFDINIR
- Active strength
- 300 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-1526-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-64bd-f424-e053-dadaa90a57ce | Cefdinir Capsules, USP Rx only |
| 53002-1526-2 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-64bd-f424-e053-dadaa90a57ce | Cefdinir Capsules, USP Rx only |
| 53002-1526-1 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-64bd-f424-e053-dadaa90a57ce | Cefdinir Capsules, USP Rx only |
| 53002-1526-2 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-64bd-f424-e053-dadaa90a57ce | Cefdinir Capsules, USP Rx only |
| 53002-1526-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-64bd-f424-e053-dadaa90a57ce | Cefdinir Capsules, USP Rx only |
| 53002-1526-2 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-64bd-f424-e053-dadaa90a57ce | Cefdinir Capsules, USP Rx only |
| 53002-1526-1 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-64bd-f424-e053-dadaa90a57ce | Cefdinir Capsules, USP Rx only |
| 53002-1526-2 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-64bd-f424-e053-dadaa90a57ce | Cefdinir Capsules, USP Rx only |
| 53002-1526-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-64bd-f424-e053-dadaa90a57ce | Cefdinir Capsules, USP Rx only |
| 53002-1526-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-64bd-f424-e053-dadaa90a57ce | Cefdinir Capsules, USP Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-1526-1 | Cefdinir | 10 in 1 BOTTLE | CAPSULE | 10 | | 5 |
| 53002-1526-2 | Cefdinir | 20 in 1 BOTTLE | CAPSULE | 20 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1526 | CEFDINIR CAPSULE [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 2 package rows | 20230609_064e3f74-9644-49bd-abef-20e1dd97794e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-1526-1 | 53002152601 | 10 CAPSULE in 1 BOTTLE (53002-1526-1) | 10 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-1526-2 | 53002152602 | 20 CAPSULE in 1 BOTTLE (53002-1526-2) | 20 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |