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NDC 00121-0820-04 THEOPHYLLINE 80 mg/15mL Details
THEOPHYLLINE 80 mg/15mL
THEOPHYLLINE is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PAI Holdings, 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: 00121-0820-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Theophylline
Product Information
| NDC | 00121-0820 |
|---|---|
| Product ID | 0121-0820_30282017-c9a7-4a0d-8c87-468e2feba567 |
| Associated GPIs | 44300040002010 |
| GCN Sequence Number | 000076 |
| GCN Sequence Number Description | theophylline anhydrous ELIXIR 80 MG/15ML ORAL |
| HIC3 | A1B |
| HIC3 Description | XANTHINES |
| GCN | 00352 |
| 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 | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 80 |
| Active Ingredient Units | mg/15mL |
| Substance Name | THEOPHYLLINE |
| Labeler Name | PAI Holdings, LLC |
| Pharmaceutical Class | Methylxanthine [EPC], Xanthines [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206344 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00121-0820-04 (00121082004)
| NDC Package Code | 0121-0820-04 |
|---|---|
| Billing NDC | 00121082004 |
| Package | 118 mL in 1 BOTTLE (0121-0820-04) |
| Marketing Start Date | 2016-12-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |