Leader Ibuprofen

Product NDC
70000-0176
11-digit product format
700000176
Labeler code
70000
Product ID
70000-0176_ead9d7b1-1a6b-4b01-9c26-35b457c93eac
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
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70000-017670000-0176-2DDiscontinued by firm2026-07-31
excluded packagepackage70000-017670000-0176-3DDiscontinued by firm2026-07-31
excluded packagepackage70000-017670000-0176-6DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072096-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1987-12-08

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leader63b8d389-7feb-41d2-8970-b7d5660ccb4a2025-08-14WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use • if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer • right before or after heart surgery Ask a doctor before use if • you have problems or serious side effects from taking pain relievers or fever reducers • the stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke • you are taking a diuretic Ask a doctor or pharmacist before use if you are • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • under a doctor’s care for any serious condition • taking any other drug When using this product • take with food or milk if stomach upset occurs Stop use and ask a doctor if • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • you have symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swelling • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially ...

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Ibuprofen
Listing expiration
2026-12-31

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
70000-0176-1Leader Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1009
70000-0176-1Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED19
70000-0176-2Leader Ibuprofen200 in 1 BOTTLETABLET, FILM COATED2009
70000-0176-2Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED19
70000-0176-3Leader Ibuprofen250 in 1 BOTTLETABLET, FILM COATED2509
70000-0176-3Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED19
70000-0176-4Leader Ibuprofen50 in 1 BOTTLETABLET, FILM COATED509
70000-0176-4Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED19
70000-0176-5Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED19
70000-0176-5Leader Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5009
70000-0176-6Leader Ibuprofen120 in 1 BOTTLETABLET, FILM COATED1209
70000-0176-6Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0176-1EA - Each70000-0176ee84ee46-ac9f-4abf-8051-c77864fe20d912018-06-11
70000-0176-2EA - Each70000-0176211e658b-111b-4c66-85b9-1197851227a712019-06-19
70000-0176-3EA - Each70000-01764c7e75ca-0627-4d04-8a00-585212b9415412018-11-06
70000-0176-4EA - Each70000-017601635ad2-bfbd-4de8-b0b0-729a2ec0d31212019-05-02
70000-0176-5EA - Each70000-01767563d36d-1451-4b46-acdd-174335fe72fc12017-12-14
70000-0176-6EA - Each70000-01768743f02d-4232-41a9-bc80-f787cde2cc6112018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0176LEADER IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER]8Current NDC, Legacy NDC, 12 package rows20230801_63b8d389-7feb-41d2-8970-b7d5660ccb4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN63b8d389-7feb-41d2-8970-b7d5660ccb4a9
310965ibuprofen 200 MG Oral TabletSCD63b8d389-7feb-41d2-8970-b7d5660ccb4a9
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY63b8d389-7feb-41d2-8970-b7d5660ccb4a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0176-1700000176011 BOTTLE in 1 CARTON (70000-0176-1) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-11-300000-00-00NoNoCurrent
70000-0176-2700000176021 BOTTLE in 1 CARTON (70000-0176-2) > 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-01-160000-00-00NoNoCurrent
70000-0176-3700000176031 BOTTLE in 1 CARTON (70000-0176-3) > 250 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-11-300000-00-00NoNoCurrent
70000-0176-4700000176041 BOTTLE in 1 CARTON (70000-0176-4) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-05-040000-00-00NoNoCurrent
70000-0176-5700000176051 BOTTLE in 1 CARTON (70000-0176-5) / 500 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-05-040000-00-00NoNoCurrent
70000-0176-6700000176061 BOTTLE in 1 CARTON (70000-0176-6) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-07-060000-00-00NoNoCurrent