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NDC 66220-0287-08 Caldolor 800 mg/8mL Details
Caldolor 800 mg/8mL
Caldolor is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cumberland Pharmaceuticals Inc.. The primary component is IBUPROFEN.
Product Information
| NDC | 66220-0287 |
|---|---|
| Product ID | 66220-287_049f2c46-6b00-429e-a4fa-d2f288e3cc48 |
| Associated GPIs | 66100020002030 |
| GCN Sequence Number | 065417 |
| GCN Sequence Number Description | ibuprofen VIAL 800MG/8ML INTRAVEN |
| HIC3 | S2B |
| HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
| GCN | 27376 |
| HICL Sequence Number | 003723 |
| HICL Sequence Number Description | IBUPROFEN |
| Brand/Generic | Brand |
| Proprietary Name | Caldolor |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ibuprofen |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 800 |
| Active Ingredient Units | mg/8mL |
| Substance Name | IBUPROFEN |
| Labeler Name | Cumberland Pharmaceuticals Inc. |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022348 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 66220-0287-08 (66220028708)
| NDC Package Code | 66220-287-08 |
|---|---|
| Billing NDC | 66220028708 |
| Package | 25 VIAL in 1 CARTON (66220-287-08) / 8 mL in 1 VIAL |
| Marketing Start Date | 2009-06-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |