Cefdinir
- Product NDC
- 68071-4007
- 11-digit product format
- 680714007
- Labeler code
- 68071
- Product ID
- 68071-4007_1d7a3d9e-4558-eb2e-e063-6294a90a8f78
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefdinir
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA065434
- Marketing category
- ANDA
- Marketing start
- 2008-01-07
- Substance
- CEFDINIR
- Active strength
- 300 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cefdinir
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CEFDINIR | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CI0FAO63WC |
| Rxcui | 200346 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-4007-1 | 2023-11-22 | C162847 | 48780-1 | ba0f9c33-1aae-a910-e053-dadaa90a0b85 | Cefdinir Capsules, USP Rx only |
| 68071-4007-2 | 2023-11-22 | C162847 | 48780-1 | ba0f9c33-1aae-a910-e053-dadaa90a0b85 | Cefdinir Capsules, USP Rx only |
| 68071-4007-3 | 2023-11-22 | C162847 | 48780-1 | ba0f9c33-1aae-a910-e053-dadaa90a0b85 | Cefdinir Capsules, USP Rx only |
| 68071-4007-1 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1aae-a910-e053-dadaa90a0b85 | Cefdinir Capsules, USP Rx only |
| 68071-4007-2 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1aae-a910-e053-dadaa90a0b85 | Cefdinir Capsules, USP Rx only |
| 68071-4007-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1aae-a910-e053-dadaa90a0b85 | Cefdinir Capsules, USP Rx only |
| 68071-4007-1 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-1aae-a910-e053-dadaa90a0b85 | Cefdinir Capsules, USP Rx only |
| 68071-4007-2 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-1aae-a910-e053-dadaa90a0b85 | Cefdinir Capsules, USP Rx only |
| 68071-4007-3 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-1aae-a910-e053-dadaa90a0b85 | Cefdinir Capsules, USP Rx only |
| 68071-4007-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1aae-a910-e053-dadaa90a0b85 | Cefdinir Capsules, USP Rx only |
| 68071-4007-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1aae-a910-e053-dadaa90a0b85 | Cefdinir Capsules, USP Rx only |
| 68071-4007-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1aae-a910-e053-dadaa90a0b85 | Cefdinir Capsules, USP Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4007-2 | Cefdinir | 20 in 1 BOTTLE | CAPSULE | 20 | | 7 |
| 68071-4007-3 | Cefdinir | 30 in 1 BOTTLE | CAPSULE | 30 | | 7 |
| 68071-4007-7 | Cefdinir | 14 in 1 BOTTLE | CAPSULE | 14 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4007 | CEFDINIR CAPSULE [NUCARE PHARMACEUTICALS,INC.] | 7 | Current NDC, Legacy NDC, 3 package rows | 20240719_54b06071-f3cb-5627-e054-00144ff8d46c.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 |
|---|
| 68071-4007-1 | 68071400701 | 14 CAPSULE in 1 BOTTLE (68071-4007-1) | 14 capsule | 2017-07-19 | 0000-00-00 | No | No | Current |
| 68071-4007-2 | 68071400702 | 20 CAPSULE in 1 BOTTLE (68071-4007-2) | 20 capsule | 2017-07-19 | 0000-00-00 | No | No | Current |
| 68071-4007-3 | 68071400703 | 30 CAPSULE in 1 BOTTLE (68071-4007-3) | 30 capsule | 2017-07-19 | 0000-00-00 | No | No | Current |
| 68071-4007-7 | 68071400707 | 14 CAPSULE in 1 BOTTLE (68071-4007-7) | 14 capsule | 2017-07-19 | | No | No | Current |