simvastatin

Generic: simvastatin

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 5 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-482
Product ID 68180-482_b78d4e8a-2261-43c6-9321-ac2539bdfd2f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078103
Listing Expiration 2027-12-31
Marketing Start 2009-07-14

Pharmacologic Class

Established (EPC)
hmg-coa reductase inhibitor [epc]
Mechanism of Action
hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180482
Hyphenated Format 68180-482

Supplemental Identifiers

RxCUI
198211 200345 312961 312962 314231
UPC
0368180478034 0368180464037 0368180479031 0368180465034
UNII
AGG2FN16EV
NUI
N0000175589 N0000000121

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name simvastatin (source: ndc)
Generic Name simvastatin (source: ndc)
Application Number ANDA078103 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Simvastatin Tablets USP, 5 mg are tan colored, round, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C01' on the other side. They are supplied as follows: NDC 68180-482-06 Bottles of 30 * NDC 68180-482-09 Bottles of 90 * NDC 68180-482-03 Bottles of 1000 * Simvastatin Tablets USP, 10 mg are peach colored, oval shaped, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C02' on the other side. They are supplied as follows: NDC 68180-478-01 Bottles of 30 NDC 68180-478-02 Bottles of 90 NDC 68180-478-03 Bottles of 1000 Simvastatin Tablets USP, 20 mg are tan colored, oval shaped, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C03' on the other side. They are supplied as follows: NDC 68180-479-01 Bottles of 30 NDC 68180-479-02 Bottles of 90 NDC 68180-479-03 Bottles of 1000 Simvastatin Tablets USP, 40 mg are brick red colored, round shaped, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C04' on the other side. They are supplied as follows: NDC 68180-464-06 Bottles of 30 NDC 68180-464-09 Bottles of 90 NDC 68180-464-03 Bottles of 1000 Simvastatin Tablets USP, 80 mg are brick red colored, capsule shaped, biconvex, film-coated tablets, debossed with 'LL' on one side and 'C05' on the other side. They are supplied as follows: NDC 68180-465-06 Bottles of 30 NDC 68180-465-09 Bottles of 90 NDC 68180-465-03 Bottles of 1000 *The 5 mg strength of Simvastatin Tablets USP is no longer being marketed. Storage Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Preserve in tight container as defined in USP.
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68180-482-03 Simvastatin Tablets USP 5 mg Each film-coated tablet contains simvastatin USP 5 mg. Rx only 1000 Tablets LUPIN NDC 68180-478-03 Simvastatin Tablets USP 10 mg Each film-coated tablet contains simvastatin USP 10 mg. Rx only 1000 Tablets LUPIN NDC 68180-479-03 Simvastatin Tablets USP 20 mg Each film-coated tablet contains simvastatin USP 20 mg. Rx only 1000 Tablets LUPIN NDC 68180-464-03 Simvastatin Tablets USP 40 mg Each film-coated tablet contains simvastatin USP 40 mg. Rx only 1000 Tablets LUPIN NDC 68180-465-03 Simvastatin Tablets USP 80 mg Each film-coated tablet contains simvastatin USP 80 mg. Rx only 1000 Tablets LUPIN Image1 Image 2 10mg-1000s Image 3 image 4 20mg-1000s Image 5 image 6 40mg-1000s image 6 image 7 80mg-1000s Image 8
source: label

Packages (0)

No package records.

Ingredients (1)

simvastatin (5 mg/1)

Linked Drug Pages (1)

SIMVASTATIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b78d4e8a-2261-43c6-9321-ac2539bdfd2f", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0368180478034", "0368180464037", "0368180479031", "0368180465034"], "unii": ["AGG2FN16EV"], "rxcui": ["198211", "200345", "312961", "312962", "314231"], "spl_set_id": ["3e48217f-8175-4e9b-9fd0-909be4bbba95"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "SIMVASTATIN", "product_id": "68180-482_b78d4e8a-2261-43c6-9321-ac2539bdfd2f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68180-482", "generic_name": "SIMVASTATIN", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SIMVASTATIN", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "5 mg/1"}], "application_number": "ANDA078103", "marketing_category": "ANDA", "marketing_start_date": "20090714", "listing_expiration_date": "20271231"}