Theophylline
- Product NDC
- 69367-414
- 11-digit product format
- 693670414
- Labeler code
- 69367
- Product ID
- 69367-414_46766222-63b4-478f-aa8b-a23b20476317
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline Anhydrous
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA040560
- Marketing category
- ANDA
- Marketing start
- 2025-11-25
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 400 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
- Brand name suffix
- (Anhydrous)
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| THEOPHYLLINE ANHYDROUS | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0I55128JYK |
| Rxcui | 313291, 348472 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69367-414-01 | Theophylline(Anhydrous) | 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 |
|---|
| 69367-414-01 | 69367041401 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-414-01) | 2025-11-25 | No | No | Current |