Theo-24
- Product NDC
- 52244-300
- 11-digit product format
- 522440300
- Labeler code
- 52244
- Product ID
- 52244-300_95d19693-50ba-43fc-81fe-6cddc537703a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- theophylline anhydrous
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- ENDO USA, Inc.
- Application
- ANDA087944
- Marketing category
- ANDA
- Marketing start
- 2014-08-25
- 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
- Theo-24
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| THEOPHYLLINE ANHYDROUS | 300 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 0I55128JYK |
| Rxcui | 198264, 313272, 313310, 701712, 844590, 844591, 844813, 844829 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d1d07c79-5983-427d-b6f5-df0550dcc598 | Product name | 4 | 20250325 |
| 7b1e3dc0-e6b1-4d5d-943b-99fdd948b5a2 | Product name | 1 | 20170302 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52244-300-10 | Theo-24 | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52244-300-10 | EA - Each | 52244-300 | 4b981261-96fe-43b9-9433-67be92b88b23 | 1 | 2015-01-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| THEOPHYLLINE ANHYDROUS | ACTIVE INGREDIENT | 0I55128JYK | THEO-24 (THEOPHYLLINE ANHYDROUS) CAPSULE, EXTENDED RELEASE [ACTIENT PHARMACEUTICALS, LLC] | 3 | |
| THEOPHYLLINE ANHYDROUS | ACTIVE MOIETY | 0I55128JYK | THEO-24 (THEOPHYLLINE ANHYDROUS) CAPSULE, EXTENDED RELEASE [ACTIENT PHARMACEUTICALS, LLC] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 844590 | Theo-24 100 MG Extended Release Oral Capsule | PSN | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 844813 | Theo-24 200 MG Extended Release Oral Capsule | PSN | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 844591 | Theo-24 300 MG Extended Release Oral Capsule | PSN | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 844829 | Theo-24 400 MG Extended Release Oral Capsule | PSN | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 701712 | theophylline 100 MG Extended Release Oral Capsule | PSN | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 313272 | theophylline 200 MG Extended Release Oral Capsule | PSN | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 313310 | theophylline 300 MG Extended Release Oral Capsule | PSN | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 198264 | theophylline 400 MG Extended Release Oral Capsule | PSN | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 844590 | theophylline 100 MG Extended Release Oral Capsule [Theo-24] | SBD | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 844813 | theophylline 200 MG Extended Release Oral Capsule [Theo-24] | SBD | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 844591 | theophylline 300 MG Extended Release Oral Capsule [Theo-24] | SBD | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 844829 | theophylline 400 MG Extended Release Oral Capsule [Theo-24] | SBD | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 701712 | theophylline 100 MG Extended Release Oral Capsule | SCD | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 313272 | theophylline 200 MG Extended Release Oral Capsule | SCD | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 313310 | theophylline 300 MG Extended Release Oral Capsule | SCD | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 198264 | theophylline 400 MG Extended Release Oral Capsule | SCD | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 844590 | Theo-24 100 MG Extended Release Oral Capsule | SY | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 844813 | Theo-24 200 MG Extended Release Oral Capsule | SY | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 844591 | Theo-24 300 MG Extended Release Oral Capsule | SY | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
| 844829 | Theo-24 400 MG Extended Release Oral Capsule | SY | 7a108fa0-c230-475f-be93-6f864b98a410 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 52244-300-10 | 52244030010 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52244-300-10) | 2014-08-25 | 0000-00-00 | No | No | Current |