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NDC 71610-0610-30 Simvastatin 40 mg/1 Details
Simvastatin 40 mg/1
Simvastatin is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is SIMVASTATIN.
Product Information
NDC | 71610-0610 |
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Product ID | 71610-610_ed131a35-eda8-4cdb-a6f0-eae48ea1c59e |
Associated GPIs | 39400075000340 |
GCN Sequence Number | 016579 |
GCN Sequence Number Description | simvastatin TABLET 40 MG ORAL |
HIC3 | M4D |
HIC3 Description | ANTIHYPERLIPIDEMIC-HMGCOA REDUCTASE INHIB(STATINS) |
GCN | 26534 |
HICL Sequence Number | 006312 |
HICL Sequence Number Description | SIMVASTATIN |
Brand/Generic | Generic |
Proprietary Name | Simvastatin |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Simvastatin |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 40 |
Active Ingredient Units | mg/1 |
Substance Name | SIMVASTATIN |
Labeler Name | Aphena Pharma Solutions - Tennessee, LLC |
Pharmaceutical Class | HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA078034 |
Listing Certified Through | 2024-12-31 |
Package
NDC 71610-0610-30 (71610061030)
NDC Package Code | 71610-610-30 |
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Billing NDC | 71610061030 |
Package | 30 TABLET, FILM COATED in 1 BOTTLE (71610-610-30) |
Marketing Start Date | 2023-03-20 |
NDC Exclude Flag | N |
Pricing Information | N/A |