Theophylline
- Product NDC
- 64380-243
- 11-digit product format
- 643800243
- Labeler code
- 64380
- Product ID
- 64380-243_86a861fa-5c70-432e-8c0b-6e7241af5e82
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- 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 | 314241, 317769 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-243-01 | Theophylline | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-243 | THEOPHYLLINE TABLET, EXTENDED RELEASE [STRIDES PHARMA SCIENCE LIMITED] | 3 | Current NDC, 1 package rows | 20240927_b7a90ccf-9c32-40cc-9008-7e55b3da4dfd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 64380-243-01 | 64380024301 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64380-243-01) | 2024-09-27 | No | No | Historical |