Theophylline
- Product NDC
- 54838-556
- 11-digit product format
- 548380556
- Labeler code
- 54838
- Product ID
- 54838-556_a2b8caa4-4d41-424e-9e92-f8fb4c86c11b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA091156
- Marketing category
- ANDA
- Marketing start
- 2011-04-13
- Marketing end
- 2024-02-29
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 80 mg/15mL
- Pharmacologic classes
- Methylxanthine [EPC], Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54838-556-80 | 54838055680 | 473 mL in 1 BOTTLE, PLASTIC (54838-556-80) | 473 ml | 2011-04-13 | 0000-00-00 | No | No | Current |