Theophylline
- Product NDC
- 72789-441
- 11-digit product format
- 727890441
- Labeler code
- 72789
- Product ID
- 72789-441_4d7b0b3d-58b1-47ad-e063-6294a90a89e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA215312
- Marketing category
- ANDA
- Marketing start
- 2024-09-27
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 300 mg/1
- Pharmacologic classes
- Methylxanthine [EPC], Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Theophylline
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| THEOPHYLLINE ANHYDROUS | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0I55128JYK |
| Rxcui | 317769 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-441-01 | Theophylline | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-441 | THEOPHYLLINE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 4 | Current NDC, 1 package rows | 20241018_c6ca5cc9-4e5e-40cf-a36e-227aa4cb55c6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-441-01 | 72789044101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-441-01) | 2024-10-16 | No | No | Current |