Theophylline
- Product NDC
- 68462-380
- 11-digit product format
- 684620380
- Labeler code
- 68462
- Product ID
- 68462-380_7c8e32e3-ca36-4ad2-971b-446c12a81992
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA090355
- Marketing category
- ANDA
- Marketing start
- 2010-07-13
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 400 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 | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0I55128JYK |
| Rxcui | 313291, 348472 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-380-01 | Theophylline | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 10 |
| 68462-380-05 | Theophylline | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| THEOPHYLLINE ANHYDROUS | ACTIVE INGREDIENT | 0I55128JYK | THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| THEOPHYLLINE ANHYDROUS | ACTIVE MOIETY | 0I55128JYK | THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) | INACTIVE INGREDIENT | ZYD53NBL45 | THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-380 | THEOPHYLLINE TABLET, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240104_56fc2167-ceb6-4e3e-8ff7-5e400dfbd533.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 |
|---|
| 68462-380-01 | 68462038001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-380-01) | 2010-07-13 | 0000-00-00 | No | No | Current |
| 68462-380-05 | 68462038005 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-380-05) | 2010-07-13 | 0000-00-00 | No | No | Current |