caldolor

Generic: ibuprofen

Labeler: cumberland pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name caldolor
Generic Name ibuprofen
Labeler cumberland pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ibuprofen 800 mg/8mL

Manufacturer
Cumberland Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 66220-287
Product ID 66220-287_42d97e40-3617-496a-96e7-d95cbd530bc6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022348
Listing Expiration 2026-12-31
Marketing Start 2009-06-11

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66220287
Hyphenated Format 66220-287

Supplemental Identifiers

RxCUI
854183 854187 2178273 2178275
UNII
WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

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 caldolor (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number NDA022348 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 800 mg/8mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (66220-287-08) / 8 mL in 1 VIAL
source: ndc

Packages (1)

66220-287-08 25 VIAL in 1 CARTON (66220-287-08) / 8 mL in 1 VIAL

Ingredients (1)

ibuprofen (800 mg/8mL)

Linked Drug Pages (1)

Caldolor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "42d97e40-3617-496a-96e7-d95cbd530bc6", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["854183", "854187", "2178273", "2178275"], "spl_set_id": ["1eaa7790-f1a1-4f51-b10a-cbbaf033f684"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Cumberland Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (66220-287-08)  / 8 mL in 1 VIAL", "package_ndc": "66220-287-08", "marketing_start_date": "20090611"}], "brand_name": "Caldolor", "product_id": "66220-287_42d97e40-3617-496a-96e7-d95cbd530bc6", "dosage_form": "INJECTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "66220-287", "generic_name": "ibuprofen", "labeler_name": "Cumberland Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Caldolor", "active_ingredients": [{"name": "IBUPROFEN", "strength": "800 mg/8mL"}], "application_number": "NDA022348", "marketing_category": "NDA", "marketing_start_date": "20090611", "listing_expiration_date": "20261231"}