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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 |
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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 |
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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 |