Theophylline
- Product NDC
- 82638-106
- 11-digit product format
- 826380106
- Labeler code
- 82638
- Product ID
- 82638-106_171269d1-329b-8551-e063-6294a90aedd7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Harman Finochem Limited
- Application
- ANDA214806
- Marketing category
- ANDA
- Marketing start
- 2024-05-31
- Substance
- THEOPHYLLINE ANHYDROUS
- 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 ANHYDROUS | 450 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0I55128JYK |
| Rxcui | 314241, 317769 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82638-106-02 | Theophylline | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82638-106 | THEOPHYLLINE TABLET, EXTENDED RELEASE [HARMAN FINOCHEM LIMITED] | 2 | Current NDC, 1 package rows | 20240531_098db8bb-fa9a-4577-b7d9-86caaefc168a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82638-106-02 | 82638010602 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (82638-106-02) | 2024-07-30 | No | No | Historical |