Theophylline
- Product NDC
- 46708-026
- 11-digit product format
- 467080026
- Labeler code
- 46708
- Product ID
- 46708-026_0d340b17-907e-4c38-bbd6-c4740495a55a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA090430
- Marketing category
- ANDA
- Marketing start
- 2010-11-01
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 450 mg/1
- Pharmacologic classes
- Methylxanthine [EPC], Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Theophylline
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| THEOPHYLLINE ANHYDROUS | 450 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0I55128JYK |
| Rxcui | 314241, 317769 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-026-30 | Theophylline | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 3 |
| 46708-026-31 | Theophylline | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 3 |
| 46708-026-71 | Theophylline | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-026 | THEOPHYLLINE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 3 package rows | 20230112_31f3c720-1597-4d43-9296-33017b90b15f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46708-026-30 | 46708002630 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-026-30) | 2010-11-01 | 0000-00-00 | No | No | Current |
| 46708-026-31 | 46708002631 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-026-31) | 2010-11-01 | 0000-00-00 | No | No | Current |
| 46708-026-71 | 46708002671 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-026-71) | 2010-11-01 | 0000-00-00 | No | No | Current |