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NDC 69315-0227-01 THEOPHYLLINE 450 mg/1 Details
THEOPHYLLINE 450 mg/1
THEOPHYLLINE is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Leading Pharma, LLC. The primary component is THEOPHYLLINE.
MedlinePlus Drug Summary
Theophylline is used to prevent and treat wheezing, shortness of breath, and chest tightness caused by asthma, chronic bronchitis, emphysema, and other lung diseases. It relaxes and opens air passages in the lungs, making it easier to breathe.
Related Packages: 69315-0227-01Last Updated: 05/05/2024
MedLinePlus Full Drug Details: Theophylline
Product Information
| NDC | 69315-0227 |
|---|---|
| Product ID | 69315-227_e3d2a7aa-e63e-479b-97d0-98bcda025b2e |
| Associated GPIs | |
| GCN Sequence Number | 000095 |
| GCN Sequence Number Description | theophylline anhydrous TAB ER 12H 450 MG ORAL |
| HIC3 | A1B |
| HIC3 Description | XANTHINES |
| GCN | 00416 |
| HICL Sequence Number | 000025 |
| HICL Sequence Number Description | THEOPHYLLINE ANHYDROUS |
| Brand/Generic | Generic |
| Proprietary Name | THEOPHYLLINE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | THEOPHYLLINE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 450 |
| Active Ingredient Units | mg/1 |
| Substance Name | THEOPHYLLINE |
| Labeler Name | Leading Pharma, LLC |
| Pharmaceutical Class | Methylxanthine [EPC], Xanthines [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA214950 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69315-0227-01 (69315022701)
| NDC Package Code | 69315-227-01 |
|---|---|
| Billing NDC | 69315022701 |
| Package | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-227-01) |
| Marketing Start Date | 2023-05-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |