Theophylline
- Product NDC
- 23155-742
- 11-digit product format
- 231550742
- Labeler code
- 23155
- Product ID
- 23155-742_c8abc0eb-6bb6-4f7b-a7bf-793cf90c5ead
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Theophylline
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA081236
- Marketing category
- ANDA
- Marketing start
- 2022-05-12
- Substance
- THEOPHYLLINE ANHYDROUS
- Active strength
- 450 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 | 450 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 |
|---|
| 23155-742-01 | Theophylline | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 4 |
| 23155-742-05 | Theophylline | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 23155-742 | THEOPHYLLINE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20220629_701fbf9c-e06b-46f4-863b-981acf3021aa.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 |
|---|
| 23155-742-01 | 23155074201 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-742-01) | 2022-05-12 | 0000-00-00 | No | No | Current |
| 23155-742-05 | 23155074205 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-742-05) | 2022-05-12 | 0000-00-00 | No | No | Current |