ibuprofen

Generic: ibuprofen

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler strides pharma science limited
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-997
Product ID 64380-997_e6705907-f479-4472-b966-ba97929f927b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215311
Listing Expiration 2026-12-31
Marketing Start 2023-09-19

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 64380997
Hyphenated Format 64380-997

Supplemental Identifiers

RxCUI
197803
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 ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA215311 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 10 CUP in 1 TRAY (64380-997-02) / 5 mL in 1 CUP (64380-997-01)
  • 1 BOTTLE in 1 CARTON (64380-997-03) / 118 mL in 1 BOTTLE
  • 473 mL in 1 BOTTLE (64380-997-04)
source: ndc

Packages (3)

64380-997-02 10 CUP in 1 TRAY (64380-997-02) / 5 mL in 1 CUP (64380-997-01) 64380-997-03 1 BOTTLE in 1 CARTON (64380-997-03) / 118 mL in 1 BOTTLE 64380-997-04 473 mL in 1 BOTTLE (64380-997-04)

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": "e6705907-f479-4472-b966-ba97929f927b", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["38ebacc3-378f-483e-babc-76119677e7df"], "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": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CUP in 1 TRAY (64380-997-02)  / 5 mL in 1 CUP (64380-997-01)", "package_ndc": "64380-997-02", "marketing_start_date": "20250326"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (64380-997-03)  / 118 mL in 1 BOTTLE", "package_ndc": "64380-997-03", "marketing_start_date": "20230919"}, {"sample": false, "description": "473 mL in 1 BOTTLE (64380-997-04)", "package_ndc": "64380-997-04", "marketing_start_date": "20230919"}], "brand_name": "Ibuprofen", "product_id": "64380-997_e6705907-f479-4472-b966-ba97929f927b", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "64380-997", "generic_name": "Ibuprofen", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA215311", "marketing_category": "ANDA", "marketing_start_date": "20230919", "listing_expiration_date": "20261231"}