dolex flex

Generic: ibuprofen

Labeler: pharmadel llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dolex flex
Generic Name ibuprofen
Labeler pharmadel llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1

Manufacturer
Pharmadel LLC

Identifiers & Regulatory

Product NDC 55758-014
Product ID 55758-014_2d557122-9692-7e4d-e063-6294a90a8651
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078682
Listing Expiration 2026-12-31
Marketing Start 2023-09-01

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 55758014
Hyphenated Format 55758-014

Supplemental Identifiers

RxCUI
310964
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 dolex flex (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA078682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (55758-014-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 50 PACKET in 1 CARTON (55758-014-99) / 2 CAPSULE, LIQUID FILLED in 1 PACKET (55758-014-02)
source: ndc

Packages (2)

55758-014-20 1 BOTTLE in 1 CARTON (55758-014-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE 55758-014-99 50 PACKET in 1 CARTON (55758-014-99) / 2 CAPSULE, LIQUID FILLED in 1 PACKET (55758-014-02)

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (1)

Dolex Flex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d557122-9692-7e4d-e063-6294a90a8651", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310964"], "spl_set_id": ["0543420d-a250-065d-e063-6294a90a005e"], "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": ["Pharmadel LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (55758-014-20)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "55758-014-20", "marketing_start_date": "20230907"}, {"sample": false, "description": "50 PACKET in 1 CARTON (55758-014-99)  / 2 CAPSULE, LIQUID FILLED in 1 PACKET (55758-014-02)", "package_ndc": "55758-014-99", "marketing_start_date": "20231101"}], "brand_name": "Dolex Flex", "product_id": "55758-014_2d557122-9692-7e4d-e063-6294a90a8651", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "55758-014", "generic_name": "Ibuprofen", "labeler_name": "Pharmadel LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dolex Flex", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA078682", "marketing_category": "ANDA", "marketing_start_date": "20230901", "listing_expiration_date": "20261231"}