Theophylline
- Product NDC
- 68462-721
- 11-digit product format
- 684620721
- Labeler code
- 68462
- Product ID
- 68462-721_588a56f6-ac5a-415e-99ac-fdb836e0202f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA212184
- Marketing category
- ANDA
- Marketing start
- 2021-06-03
- 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 | 314241, 317769 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-721-01 | Theophylline | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 3 |
| 68462-721-05 | Theophylline | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 3 |
| 68462-721-10 | Theophylline | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 3 |
| 68462-721-30 | Theophylline | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-721 | THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 2 | Current NDC, Legacy NDC, 4 package rows | 20240105_48330a8e-be08-4d38-b8b1-d30fbd5a35de.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68462-721-01 | 68462072101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-01) | 2021-06-03 | 0000-00-00 | No | No | Current |
| 68462-721-05 | 68462072105 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-05) | 2021-06-03 | 0000-00-00 | No | No | Current |
| 68462-721-10 | 68462072110 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-10) | 2021-06-03 | 0000-00-00 | No | No | Current |
| 68462-721-30 | 68462072130 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-30) | 2021-06-03 | 0000-00-00 | No | No | Current |