Theophylline
- Product NDC
- 72789-441
- 11-digit product format
- 727890441
- Labeler code
- 72789
- Product ID
- 72789-441_4d7b0b3d-58b1-47ad-e063-6294a90a89e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA215312
- Marketing category
- ANDA
- Marketing start
- 2024-09-27
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 300 mg/1
- Pharmacologic classes
- Methylxanthine [EPC], Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 0I55128JYK | THEOPHYLLINE ANHYDROUS | 58-55-9 | THEOPHYLLINE ANHYDROUS |
| C137DTR5RG | THEOPHYLLINE | 5967-84-0 | Theophylline |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-441-01 | 72789044101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-441-01) | 2024-10-16 | No | No | Historical |