| Product NDC: | 54838-556 |
| Proprietary Name: | Theophylline |
| Non Proprietary Name: | Theophylline |
| Active Ingredient(s): | 80 mg/15mL & nbsp; Theophylline |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 54838-556 |
| Labeler Name: | Silarx Pharmaceuticals, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA091156 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20110413 |
| Package NDC: | 54838-556-80 |
| Package Description: | 473 mL in 1 BOTTLE, PLASTIC (54838-556-80) |
| NDC Code | 54838-556-80 |
| Proprietary Name | Theophylline |
| Package Description | 473 mL in 1 BOTTLE, PLASTIC (54838-556-80) |
| Product NDC | 54838-556 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Theophylline |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 20110413 |
| Marketing Category Name | ANDA |
| Labeler Name | Silarx Pharmaceuticals, Inc |
| Substance Name | THEOPHYLLINE ANHYDROUS |
| Strength Number | 80 |
| Strength Unit | mg/15mL |
| Pharmaceutical Classes | Methylxanthine [EPC],Xanthines [Chemical/Ingredient] |