Theophylline is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is Theophylline Anhydrous.
| Product ID | 10135-604_d21b83e5-364a-44c4-ae8c-a371ff5aeb22 |
| NDC | 10135-604 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Theophylline |
| Generic Name | Theophylline Anhydrous |
| Dosage Form | Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2016-02-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA091156 |
| Labeler Name | Marlex Pharmaceuticals Inc |
| Substance Name | THEOPHYLLINE ANHYDROUS |
| Active Ingredient Strength | 80 mg/15mL |
| Pharm Classes | Methylxanthine [EPC],Xanthines [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2016-02-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA091156 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-02-01 |
| Ingredient | Strength |
|---|---|
| THEOPHYLLINE ANHYDROUS | 80 mg/15mL |
| 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 |
| 68151-1393 | Theophylline | Theophylline |
| 68462-380 | Theophylline | Theophylline |
| 68462-356 | Theophylline | Theophylline |
| 68788-0453 | Theophylline | Theophylline |
| 50111-518 | Theophylline | Theophylline |
| 50111-483 | 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 |
| 17856-0644 | ELIXOPHYLLIN | THEOPHYLLINE ANHYDROUS |
| 49708-644 | ELIXOPHYLLIN | THEOPHYLLINE ANHYDROUS |
| 16571-011 | Theophylline(Anhydrous) | Theophylline |