Theophylline
- Product NDC
- 69452-267
- 11-digit product format
- 694520267
- Labeler code
- 69452
- Product ID
- 69452-267_07895277-4273-508f-e063-6394a90a40ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bionpharma Inc.,
- Application
- ANDA216300
- Marketing category
- ANDA
- Marketing start
- 2023-10-12
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 300 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 | 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 |
|---|
| 69452-267-20 | 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 |
|---|
| 69452-267 | THEOPHYLLINE TABLET, EXTENDED RELEASE [BIONPHARMA INC.,] | 1 | Current NDC, 1 package rows | 20231013_63517422-45a0-4e78-8505-eca054068ee9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69452-267-20 | 69452026720 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69452-267-20) | 2023-10-12 | No | No | Current |