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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NIFEDIPINE | ACTIVE INGREDIENT | I9ZF7L6G2L | NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| NIFEDIPINE | ACTIVE MOIETY | I9ZF7L6G2L | NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | INACTIVE INGREDIENT | S38J6RZN16 | NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) | INACTIVE INGREDIENT | 5KY68S2577 | NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 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 |