Theophylline
- Product NDC
- 0378-0486
- 11-digit product format
- 003780486
- Labeler code
- 0378
- Product ID
- 0378-0486_c643fde6-233c-4d44-b3dc-51243f1d0337
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA040560
- Marketing category
- ANDA
- Marketing start
- 2017-03-07
- Marketing end
- 2022-07-31
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 400 mg/1
- 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-0486-01 | 00378048601 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0486-01) | 2017-03-07 | 2022-07-31 | No | No | Current |