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NDC 61919-0463-21 IBUPROFEN 800 mg/1 Details
IBUPROFEN 800 mg/1
IBUPROFEN is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Direct_Rx. The primary component is IBUPROFEN.
Product Information
NDC | 61919-0463 |
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Product ID | 61919-463_f9a07d5a-f523-0572-e053-6394a90a8aba |
Associated GPIs | 66100020000340 |
GCN Sequence Number | 008350 |
GCN Sequence Number Description | ibuprofen TABLET 800 MG ORAL |
HIC3 | S2B |
HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
GCN | 35744 |
HICL Sequence Number | 003723 |
HICL Sequence Number Description | IBUPROFEN |
Brand/Generic | Generic |
Proprietary Name | IBUPROFEN |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | IBUOROFEN |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 800 |
Active Ingredient Units | mg/1 |
Substance Name | IBUPROFEN |
Labeler Name | Direct_Rx |
Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA091625 |
Listing Certified Through | 2024-12-31 |
Package
NDC 61919-0463-21 (61919046321)
NDC Package Code | 61919-463-21 |
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Billing NDC | 61919046321 |
Package | 21 TABLET, FILM COATED in 1 BOTTLE (61919-463-21) |
Marketing Start Date | 2019-08-22 |
NDC Exclude Flag | N |
Pricing Information | N/A |