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NDC 68462-0380-05 Theophylline 400 mg/1 Details
Theophylline 400 mg/1
Theophylline is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., USA. The primary component is THEOPHYLLINE ANHYDROUS.
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: 68462-0380-05Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Theophylline
Product Information
| NDC | 68462-0380 |
|---|---|
| Product ID | 68462-380_aaa6684e-4eef-42a8-92b6-8f317e570903 |
| Associated GPIs | 44300040007540 |
| GCN Sequence Number | 000094 |
| GCN Sequence Number Description | theophylline anhydrous TAB ER 24H 400 MG ORAL |
| HIC3 | A1B |
| HIC3 Description | XANTHINES |
| GCN | 00415 |
| 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 | 400 |
| Active Ingredient Units | mg/1 |
| Substance Name | THEOPHYLLINE ANHYDROUS |
| Labeler Name | Glenmark Pharmaceuticals Inc., USA |
| Pharmaceutical Class | Methylxanthine [EPC], Xanthines [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090355 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 68462-0380-05 (68462038005)
| NDC Package Code | 68462-380-05 |
|---|---|
| Billing NDC | 68462038005 |
| Package | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-380-05) |
| Marketing Start Date | 2010-07-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |