ibuprofen

Generic: ibuprofen

Labeler: atlantic biologicals corp.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler atlantic biologicals corp.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-5309
Product ID 17856-5309_34f37e2c-ba78-120a-e063-6294a90aa750
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074937
Listing Expiration 2026-12-31
Marketing Start 1999-02-07

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 178565309
Hyphenated Format 17856-5309

Supplemental Identifiers

RxCUI
197803
UNII
WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

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 ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA074937 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 5 mL in 1 SYRINGE (17856-5309-1)
  • 10 mL in 1 SYRINGE (17856-5309-2)
  • 20 mL in 1 CUP (17856-5309-4)
  • 5 mL in 1 CUP (17856-5309-5)
  • 15 mL in 1 CUP (17856-5309-6)
  • 7.5 mL in 1 CUP, UNIT-DOSE (17856-5309-7)
  • 72 CUP, UNIT-DOSE in 1 CASE (17856-5309-8) / 10 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (7)

17856-5309-1 5 mL in 1 SYRINGE (17856-5309-1) 17856-5309-2 10 mL in 1 SYRINGE (17856-5309-2) 17856-5309-4 20 mL in 1 CUP (17856-5309-4) 17856-5309-5 5 mL in 1 CUP (17856-5309-5) 17856-5309-6 15 mL in 1 CUP (17856-5309-6) 17856-5309-7 7.5 mL in 1 CUP, UNIT-DOSE (17856-5309-7) 17856-5309-8 72 CUP, UNIT-DOSE in 1 CASE (17856-5309-8) / 10 mL in 1 CUP, UNIT-DOSE

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "34f37e2c-ba78-120a-e063-6294a90aa750", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["230914e6-fe0c-45be-8b2e-e066c71d004c"], "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": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 SYRINGE (17856-5309-1)", "package_ndc": "17856-5309-1", "marketing_start_date": "20210128"}, {"sample": false, "description": "10 mL in 1 SYRINGE (17856-5309-2)", "package_ndc": "17856-5309-2", "marketing_start_date": "20190920"}, {"sample": false, "description": "20 mL in 1 CUP (17856-5309-4)", "package_ndc": "17856-5309-4", "marketing_start_date": "20210128"}, {"sample": false, "description": "5 mL in 1 CUP (17856-5309-5)", "package_ndc": "17856-5309-5", "marketing_start_date": "20210128"}, {"sample": false, "description": "15 mL in 1 CUP (17856-5309-6)", "package_ndc": "17856-5309-6", "marketing_start_date": "20210128"}, {"sample": false, "description": "7.5 mL in 1 CUP, UNIT-DOSE (17856-5309-7)", "package_ndc": "17856-5309-7", "marketing_start_date": "20210128"}, {"sample": false, "description": "72 CUP, UNIT-DOSE in 1 CASE (17856-5309-8)  / 10 mL in 1 CUP, UNIT-DOSE", "package_ndc": "17856-5309-8", "marketing_start_date": "20250402"}], "brand_name": "Ibuprofen", "product_id": "17856-5309_34f37e2c-ba78-120a-e063-6294a90aa750", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "17856-5309", "generic_name": "Ibuprofen", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA074937", "marketing_category": "ANDA", "marketing_start_date": "19990207", "listing_expiration_date": "20261231"}