FDA.reportPublic FDA data

Leader Ibuprofen

Product NDC
70000-0175
11-digit product format
700000175
Labeler code
70000
Product ID
70000-0175_2235a36b-14ac-4a95-8616-6d51f2ce5c1f
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA072096
Marketing category
ANDA
Marketing start
2016-11-30
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Ibuprofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0175-1Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-1Leader Ibuprofen24 in 1 BOTTLETABLET, FILM COATED2414
70000-0175-2Leader Ibuprofen50 in 1 BOTTLETABLET, FILM COATED5014
70000-0175-2Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-3Leader Ibuprofen100 in 1 BOTTLETABLET, FILM COATED10014
70000-0175-3Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-4Leader Ibuprofen250 in 1 BOTTLETABLET, FILM COATED25014
70000-0175-4Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-5Leader Ibuprofen500 in 1 BOTTLETABLET, FILM COATED50014
70000-0175-6Leader Ibuprofen2 in 1 POUCHTABLET, FILM COATED214
70000-0175-7Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-7Leader Ibuprofen120 in 1 BOTTLETABLET, FILM COATED12014
70000-0175-8Leader Ibuprofen200 in 1 BOTTLETABLET, FILM COATED20014
70000-0175-8Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-9Leader Ibuprofen250 in 1 BOTTLETABLET, FILM COATED25014
70000-0175-9Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0175-1EA - Each70000-017569331b86-344b-43ea-9142-f19e3f2aa51f12018-05-09
70000-0175-2EA - Each70000-01753ba5d489-6fe5-403a-ad1e-cc378451532a12019-05-02
70000-0175-3EA - Each70000-01752d323018-e0fc-4664-acf2-a496613a8e8e12017-12-14
70000-0175-4EA - Each70000-017564aacbd6-54c7-46f4-b8c0-3160722ad7d512017-12-14
70000-0175-5EA - Each70000-0175c2b24f47-61b9-4519-9d4c-fcfab1369cf012017-12-14
70000-0175-7EA - Each70000-0175d8cec946-a77d-4c4d-91f1-d2a395641fc012018-03-08
70000-0175-8EA - Each70000-0175883670c7-42c4-4862-bc1c-53ce4757609d12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0175LEADER IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER]12Current NDC, Legacy NDC, 16 package rows20240131_d673266c-3d2b-479f-9b53-cdd1b8651393.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNd673266c-3d2b-479f-9b53-cdd1b865139314
310965ibuprofen 200 MG Oral TabletSCDd673266c-3d2b-479f-9b53-cdd1b865139314
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYd673266c-3d2b-479f-9b53-cdd1b865139314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0175-1700000175011 BOTTLE in 1 CARTON (70000-0175-1) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-11-300000-00-00NoNoCurrent
70000-0175-2700000175021 BOTTLE in 1 CARTON (70000-0175-2) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-04-290000-00-00NoNoCurrent
70000-0175-3700000175031 BOTTLE in 1 CARTON (70000-0175-3) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-05-040000-00-00NoNoCurrent
70000-0175-4700000175041 BOTTLE in 1 CARTON (70000-0175-4) > 250 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-06-162022-02-28NoNoCurrent
70000-0175-570000017505500 TABLET, FILM COATED in 1 BOTTLE (70000-0175-5) 2017-05-230000-00-00NoNoCurrent
70000-0175-6700000175062 TABLET, FILM COATED in 1 POUCH (70000-0175-6) 2017-07-060000-00-00NoNoCurrent
70000-0175-7700000175071 BOTTLE in 1 CARTON (70000-0175-7) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-07-060000-00-00NoNoCurrent
70000-0175-8700000175081 BOTTLE in 1 CARTON (70000-0175-8) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-10-010000-00-00NoNoCurrent
70000-0175-9700000175091 BOTTLE in 1 CARTON (70000-0175-9) / 250 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-01-292026-10-31NoNoHistorical