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NDC 62135-0556-47 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 Chartwell RX, LLC. The primary component is THEOPHYLLINE ANHYDROUS.
Product Information
| NDC | 62135-0556 |
|---|---|
| Product ID | 62135-556_06fd175e-7ec0-fe99-e063-6294a90ab489 |
| Associated GPIs | |
| GCN Sequence Number | 000077 |
| GCN Sequence Number Description | theophylline anhydrous SOLUTION 80 MG/15ML ORAL |
| HIC3 | A1B |
| HIC3 Description | XANTHINES |
| GCN | 01080 |
| 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 ANHYDROUS |
| Labeler Name | Chartwell RX, LLC |
| Pharmaceutical Class | Methylxanthine [EPC], Xanthines [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091156 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 62135-0556-47 (62135055647)
| NDC Package Code | 62135-556-47 |
|---|---|
| Billing NDC | 62135055647 |
| Package | 473 mL in 1 BOTTLE (62135-556-47) |
| Marketing Start Date | 2022-10-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |