Theophylline
- Product NDC
- 0480-3309
- 11-digit product format
- 004803309
- Labeler code
- 0480
- Product ID
- 0480-3309_287dcdda-ce6b-4949-bf12-4316f1f4fe00
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA216961
- Marketing category
- ANDA
- Marketing start
- 2023-01-27
- Substance
- THEOPHYLLINE
- 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 | 450 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C137DTR5RG |
| Rxcui | 314241, 317769 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0480-3309-01 | Theophylline | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0480-3309 | THEOPHYLLINE TABLET, EXTENDED RELEASE [TEVA PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20231205_25eabefa-518b-4030-9b72-01ac8b3deba9.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 |
|---|
| 0480-3309-01 | 00480330901 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0480-3309-01) | 2023-01-27 | 0000-00-00 | No | No | Current |