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NDC 68180-0802-16 RUFINAMIDE 100 mg/1 Details
RUFINAMIDE 100 mg/1
RUFINAMIDE is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is RUFINAMIDE.
Product Information
NDC | 68180-0802 |
---|---|
Product ID | 68180-802_29588ca0-0dde-4a46-be19-0e58db8baa49 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | RUFINAMIDE |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | rufinamide |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 100 |
Active Ingredient Units | mg/1 |
Substance Name | RUFINAMIDE |
Labeler Name | Lupin Pharmaceuticals, Inc. |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA204964 |
Listing Certified Through | 2023-12-31 |
Package
NDC 68180-0802-16 (68180080216)
NDC Package Code | 68180-802-16 |
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Billing NDC | 68180080216 |
Package | 120 TABLET, FILM COATED in 1 BOTTLE (68180-802-16) |
Marketing Start Date | 2022-11-28 |
NDC Exclude Flag | N |
Pricing Information | N/A |