FDA.reportPublic FDA data

Ibuprofen

Product NDC
70000-0571
11-digit product format
700000571
Labeler code
70000
Product ID
70000-0571_dc8d76a0-1607-4304-b442-9f61392bdb41
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Cardinal Health (Leader) 70000
Application
ANDA078682
Marketing category
ANDA
Marketing start
2021-04-30
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310964

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
70000-0571-1Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED14
70000-0571-1Ibuprofen20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED204
70000-0571-2Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED14
70000-0571-2Ibuprofen40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED404
70000-0571-3Ibuprofen80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0571-1EA - Each70000-057190db4748-1630-4bd8-a5b1-23c9f43667fc12022-02-07
70000-0571-2EA - Each70000-0571ebf2228f-606c-4a7e-8818-4593e51dae7112022-02-07
70000-0571-3EA - Each70000-05719c1d50cd-d135-4943-a8fb-01fecb3fa90b12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0571IBUPROFEN CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 70000]4Current NDC, Legacy NDC, 5 package rows20230312_e751cb66-5fa5-4171-b061-da34aa10de6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSNe751cb66-5fa5-4171-b061-da34aa10de6c4
310964ibuprofen 200 MG Oral CapsuleSCDe751cb66-5fa5-4171-b061-da34aa10de6c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0571-1700000571011 BOTTLE, PLASTIC in 1 BOX (70000-0571-1) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-04-300000-00-00NoNoCurrent
70000-0571-2700000571021 BOTTLE, PLASTIC in 1 BOX (70000-0571-2) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-04-300000-00-00NoNoCurrent
70000-0571-37000005710380 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70000-0571-3) 2021-04-300000-00-00NoNoCurrent