Theophylline
- Product NDC
- 53808-0982
- 11-digit product format
- 538080982
- Labeler code
- 53808
- Product ID
- 53808-0982_c0b718f4-95ea-4a9a-b926-4b9f16dc0714
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA090430
- Marketing category
- ANDA
- Marketing start
- 2013-01-01
- Marketing end
- 0000-00-00
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 300 mg/1
- Pharmacologic classes
- Methylxanthine [EPC],Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53808-0982-2 | Theophylline | 60 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 60 | | 2 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53808-0982 | THEOPHYLLINE TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | Legacy NDC, 1 package rows | 20140430_88d863a5-63ab-4b29-b181-6d7db38234ba.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53808-0982-2 | 53808098202 | 60 in 1 BLISTER PACK | Historical |