Theophylline is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals, Inc.. The primary component is Theophylline.
| Product ID | 0480-3309_f7ebf68c-3476-4368-b5d9-4bfd523f3c42 |
| NDC | 0480-3309 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Theophylline |
| Generic Name | Theophylline |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-10-31 |
| Marketing Category | ANDA / |
| Application Number | ANDA216961 |
| Labeler Name | Teva Pharmaceuticals, Inc. |
| Substance Name | THEOPHYLLINE |
| Active Ingredient Strength | 450 mg/1 |
| Pharm Classes | Methylxanthine [EPC], Xanthines [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2022-10-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0121-0820 | THEOPHYLLINE | THEOPHYLLINE |
| 0121-4794 | Theophylline | THEOPHYLLINE ANHYDROUS |
| 0121-4820 | THEOPHYLLINE | THEOPHYLLINE |
| 0378-0486 | Theophylline | Theophylline |
| 0378-0487 | Theophylline | Theophylline |
| 0480-3309 | Theophylline | Theophylline |
| 0480-3310 | Theophylline | Theophylline |
| 10135-604 | Theophylline | Theophylline Anhydrous |
| 17856-0038 | Theophylline | Theophylline |
| 23155-741 | Theophylline | Theophylline |
| 23155-742 | Theophylline | Theophylline |
| 27808-033 | Theophylline | Theophylline |
| 29033-001 | Theophylline | Theophylline |
| 29033-002 | Theophylline | Theophylline |
| 42858-701 | Theophylline | Theophylline |
| 42858-702 | Theophylline | Theophylline |
| 46708-025 | Theophylline | Theophylline |
| 46708-026 | Theophylline | Theophylline |
| 50111-459 | Theophylline | Theophylline |
| 50111-482 | Theophylline | Theophylline |
| 50111-483 | Theophylline | Theophylline |
| 50111-518 | Theophylline | Theophylline |
| 68151-1393 | Theophylline | Theophylline |
| 68462-380 | Theophylline | Theophylline |
| 68462-356 | Theophylline | Theophylline |
| 68788-0453 | Theophylline | Theophylline |
| 53808-0982 | Theophylline | Theophylline |
| 54838-556 | Theophylline | Theophylline |
| 60621-033 | Theophylline | Theophylline |
| 60687-258 | Theophylline | Theophylline |
| 62332-026 | Theophylline | Theophylline |
| 62332-025 | Theophylline | Theophylline |
| 63629-5198 | Theophylline | Theophylline |
| 63629-2792 | Theophylline | Theophylline |
| 16571-011 | Theophylline(Anhydrous) | Theophylline |