Theophylline
- Product NDC
- 50111-459
- 11-digit product format
- 501110459
- Labeler code
- 50111
- Product ID
- 50111-459_7ead0af5-da03-4e84-8685-f469cfde4855
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA089763
- Marketing category
- ANDA
- Marketing start
- 2010-09-13
- Marketing end
- 0000-00-00
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 300 mg/1
- Pharmacologic classes
- Methylxanthine [EPC],Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| THEOPHYLLINE ANHYDROUS | ACTIVE INGREDIENT | 0I55128JYK | THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| THEOPHYLLINE ANHYDROUS | ACTIVE MOIETY | 0I55128JYK | THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYPROMELLOSE 2208 (100 MPA.S) | INACTIVE INGREDIENT | B1QE5P712K | THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYPROMELLOSE 2208 (100000 MPA.S) | INACTIVE INGREDIENT | VM7F0B23ZI | THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | THEOPHYLLINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed RxNorm Mappings#