Theophylline
- Product NDC
- 71321-501
- 11-digit product format
- 713210501
- Labeler code
- 71321
- Product ID
- 71321-501_9c1ede62-fd47-41f4-96da-93d65133042d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Brandywine Pharmaceuticals, LLC
- Application
- ANDA087400
- Marketing category
- ANDA
- Marketing start
- 2025-09-30
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 200 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0I55128JYK |
| Rxcui | 237178, 317769, 346574 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71321-501-10 | Theophylline | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71321-501-10 | 71321050110 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71321-501-10) | 2025-09-30 | No | No | Current |