Theophylline
- Product NDC
- 17856-0038
- 11-digit product format
- 178560038
- Labeler code
- 17856
- Product ID
- 17856-0038_4524c143-c24e-c35b-e063-6394a90acc56
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Application
- ANDA091586
- Marketing category
- ANDA
- Marketing start
- 2012-08-02
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 80 mg/15mL
- 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 | 80 mg/15mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0I55128JYK |
| Rxcui | 313306 |
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 |
|---|
| 17856-0038-1 | Theophylline | 15 mL in 1 CUP, UNIT-DOSE | SOLUTION | 15 | | 5 |
| 17856-0038-1 | Theophylline | 50 in 1 BOX, UNIT-DOSE | SOLUTION | 50 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17856-0038 | THEOPHYLLINE SOLUTION [ATLANTIC BIOLOGICALS CORP.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250529_47e484c2-f59e-4a71-bb97-c90f128ac345.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 |
|---|
| 17856-0038-1 | 17856003801 | 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0038-1) / 15 mL in 1 CUP, UNIT-DOSE | 2024-05-09 | 0000-00-00 | No | No | Current |