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NDC 00480-3309-01 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 Teva Pharmaceuticals, Inc.. The primary component is THEOPHYLLINE.
Product Information
| NDC | 00480-3309 |
|---|---|
| Product ID | 0480-3309_287dcdda-ce6b-4949-bf12-4316f1f4fe00 |
| 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 | Teva Pharmaceuticals, Inc. |
| Pharmaceutical Class | Methylxanthine [EPC], Xanthines [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA216961 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00480-3309-01 (00480330901)
| NDC Package Code | 0480-3309-01 |
|---|---|
| Billing NDC | 00480330901 |
| Package | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0480-3309-01) |
| Marketing Start Date | 2023-01-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |