THEOPHYLLINE
- Product NDC
- 69315-227
- 11-digit product format
- 693150227
- Labeler code
- 69315
- Product ID
- 69315-227_a7dacdee-6f6b-4b85-b051-7779258a6971
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- THEOPHYLLINE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Leading Pharma, LLC
- Application
- ANDA214950
- Marketing category
- ANDA
- Marketing start
- 2023-05-15
- 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 |
|---|
| 69315-227-01 | THEOPHYLLINE | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-227 | THEOPHYLLINE TABLET, EXTENDED RELEASE [LEADING PHARMA, LLC] | 8 | Current NDC, 1 package rows | 20241009_ac490ebf-24e1-47c4-a932-ad4dcafe7aad.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69315-227-01 | 69315022701 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-227-01) | 2023-05-15 | No | No | Historical |