theophylline
- Product NDC
- 60219-2045
- 11-digit product format
- 602192045
- Labeler code
- 60219
- Product ID
- 60219-2045_8d9dfe98-c0ba-44aa-a349-33c8d0a8bbdf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA216276
- Marketing category
- ANDA
- Marketing start
- 2023-03-27
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 300 mg/1
- 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 | 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 |
|---|
| 60219-2045-1 | theophylline | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | | 3 |
| 60219-2045-3 | theophylline | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 3 |
| 60219-2045-5 | theophylline | 500 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 500 | | 3 |
| 60219-2045-7 | theophylline | 1000 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60219-2045 | THEOPHYLLINE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC] | 3 | Current NDC, 4 package rows | 20230327_b0d5d1cd-c79b-4229-929c-2eb3e4f43298.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 60219-2045-1 | 60219204501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-1) | 2023-03-27 | No | No | Historical |
| 60219-2045-3 | 60219204503 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-3) | 2023-03-27 | No | No | Historical |
| 60219-2045-5 | 60219204505 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-5) | 2023-03-27 | No | No | Historical |
| 60219-2045-7 | 60219204507 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2045-7) | 2023-03-27 | No | No | Historical |