Nifedipine is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Nifedipine.
| Product ID | 0378-0353_d5517e8c-6f72-4ee3-967c-e60b00266b9f |
| NDC | 0378-0353 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Nifedipine |
| Generic Name | Nifedipine |
| Dosage Form | Tablet, Film Coated, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2010-12-20 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA201071 |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | NIFEDIPINE |
| Active Ingredient Strength | 30 mg/1 |
| Pharm Classes | Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2010-12-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA201071 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-12-20 |
| Marketing Category | ANDA |
| Application Number | ANDA201071 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-12-20 |
| Marketing Category | ANDA |
| Application Number | ANDA201071 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-12-20 |
| Marketing End Date | 2014-01-27 |
| Ingredient | Strength |
|---|---|
| NIFEDIPINE | 30 mg/1 |
| SPL SET ID: | 49040b3a-0802-4a7d-b0c9-c7f47c1bbe10 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0228-2497 | Nifedipine | Nifedipine |
| 0228-2530 | Nifedipine | Nifedipine |
| 0378-0353 | Nifedipine | nifedipine |
| 0378-0360 | Nifedipine | nifedipine |
| 0378-0390 | Nifedipine | nifedipine |
| 0378-0480 | Nifedipine | nifedipine |
| 0378-0481 | Nifedipine | nifedipine |
| 0378-0494 | Nifedipine | nifedipine |
| 0615-5541 | Nifedipine | nifedipine |
| 0615-6563 | Nifedipine | nifedipine |
| 0615-7571 | Nifedipine | Nifedipine |
| 0904-6544 | Nifedipine | Nifedipine |
| 0904-6545 | Nifedipine | Nifedipine |
| 0904-7080 | Nifedipine | nifedipine |
| 0904-7081 | Nifedipine | nifedipine |
| 0904-7082 | Nifedipine | nifedipine |
| 0904-7208 | Nifedipine | Nifedipine |
| 0904-7229 | Nifedipine | Nifedipine |
| 10370-677 | Nifedipine | Nifedipine |
| 10370-678 | Nifedipine | Nifedipine |
| 10370-679 | Nifedipine | Nifedipine |
| 21695-807 | nifedipine | nifedipine |
| 21695-908 | nifedipine | nifedipine |
| 21695-909 | Nifedipine | Nifedipine |
| 23155-194 | Nifedipine | Nifedipine |
| 23155-195 | Nifedipine | Nifedipine |
| 68071-3025 | Nifedipine | Nifedipine |
| 68071-3287 | Nifedipine | Nifedipine |
| 68071-3036 | Nifedipine | Nifedipine |
| 68071-3315 | Nifedipine | Nifedipine |
| 68071-3382 | Nifedipine | Nifedipine |
| 68071-3347 | Nifedipine | Nifedipine |
| 68071-4097 | Nifedipine | Nifedipine |
| 68071-3281 | NIFEdipine | NIFEdipine |
| 68071-4334 | Nifedipine | Nifedipine |
| 68071-3364 | Nifedipine | Nifedipine |
| 68071-4411 | Nifedipine | Nifedipine |
| 68071-4281 | nifedipine | nifedipine |
| 68071-4558 | Nifedipine | Nifedipine |
| 68084-022 | Nifedipine | Nifedipine |
| 68084-603 | Nifedipine | Nifedipine |
| 68084-598 | Nifedipine | Nifedipine |
| 68084-923 | Nifedipine | Nifedipine |
| 68084-597 | Nifedipine | Nifedipine |
| 68151-2870 | Nifedipine | Nifedipine |
| 68382-685 | Nifedipine | Nifedipine |
| 68382-690 | NIFEDIPINE | NIFEDIPINE |
| 68382-687 | Nifedipine | Nifedipine |
| 68382-686 | Nifedipine | Nifedipine |
| 68382-688 | NIFEDIPINE | NIFEDIPINE |