Theophylline is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Inc.. The primary component is Theophylline Anhydrous.
| Product ID | 62332-025_7a8aa79d-1f91-4728-80c4-8d92b0b4af05 | 
| NDC | 62332-025 | 
| Product Type | Human Prescription Drug | 
| Proprietary Name | Theophylline | 
| Generic Name | Theophylline | 
| Dosage Form | Tablet, Extended Release | 
| Route of Administration | ORAL | 
| Marketing Start Date | 2016-01-29 | 
| Marketing Category | ANDA / ANDA | 
| Application Number | ANDA090430 | 
| Labeler Name | Alembic Pharmaceuticals Inc. | 
| Substance Name | THEOPHYLLINE ANHYDROUS | 
| Active Ingredient Strength | 300 mg/1 | 
| Pharm Classes | Methylxanthine [EPC],Xanthines [CS] | 
| NDC Exclude Flag | N | 
| Listing Certified Through | 2020-12-31 | 
| Marketing Start Date | 2016-01-29 | 
| NDC Exclude Flag | N | 
| Sample Package? | N | 
| Marketing Category | ANDA | 
| Application Number | ANDA090430 | 
| Product Type | HUMAN PRESCRIPTION DRUG | 
| Marketing Start Date | 2016-01-29 | 
| Marketing Category | ANDA | 
| Application Number | ANDA090430 | 
| Product Type | HUMAN PRESCRIPTION DRUG | 
| Marketing Start Date | 2016-01-29 | 
| Marketing Category | ANDA | 
| Application Number | ANDA090430 | 
| Product Type | HUMAN PRESCRIPTION DRUG | 
| Marketing Start Date | 2016-01-29 | 
| Marketing Category | ANDA | 
| Application Number | ANDA090430 | 
| Product Type | HUMAN PRESCRIPTION DRUG | 
| Billing Unit | EA | 
| Marketing Start Date | 2016-01-29 | 
| Ingredient | Strength | 
|---|---|
| THEOPHYLLINE ANHYDROUS | 300 mg/1 | 
| SPL SET ID: | 77e849b8-900b-4f0d-ac5c-1391abcd5721 | 
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code | 
| 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 |