Theophylline
- Product NDC
- 72578-174
- 11-digit product format
- 725780174
- Labeler code
- 72578
- Product ID
- 72578-174_1e5a0f45-86aa-498a-9cc3-9f7acc210ed6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Viona Pharmaceuticals Inc
- Application
- ANDA218063
- Marketing category
- ANDA
- Marketing start
- 2024-05-25
- 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 |
|---|
| 72578-174-01 | Theophylline | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72578-174 | THEOPHYLLINE TABLET, EXTENDED RELEASE [VIONA PHARMACEUTICALS INC] | 1 | Current NDC, 1 package rows | 20240528_abdfb9b9-9402-4761-9347-8eb1c4d86242.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72578-174-01 | 72578017401 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-174-01) | 2024-05-25 | No | No | Historical |