NifedicalXL
- Product NDC
- 53217-010
- 11-digit product format
- 532170010
- Labeler code
- 53217
- Product ID
- 53217-010_c8bbdb77-8cb5-437b-96b7-a064ba98c84d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nifedipine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA075289
- Marketing category
- ANDA
- Marketing start
- 2000-12-11
- Marketing end
- 0000-00-00
- Substance
- NIFEDIPINE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-010-30 | NifedicalXLXL | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 30 | | 1 |
| 53217-010-60 | NifedicalXLXL | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 60 | | 1 |
| 53217-010-90 | NifedicalXLXL | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-010 | NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 3 package rows | 20140214_2b62f40a-610e-4f37-8798-eaa7bf9377cd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-010-30 | 53217001030 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 53217-010-60 | 53217001060 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 53217-010-90 | 53217001090 | 90 in 1 BOTTLE, PLASTIC | Historical |