FDA.reportPublic FDA data

Ibuprofen

Product NDC
63868-570
11-digit product format
638680570
Labeler code
63868
Product ID
63868-570_459b3c6b-39d6-a4d6-e063-6394a90a9350
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
ANDA202312
Marketing category
ANDA
Marketing start
2020-03-25
Marketing end
2027-04-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen

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
63868-570-01Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, COATED1003
63868-570-01Ibuprofen1 in 1 CARTONTABLET, COATED13
63868-570-50Ibuprofen1 in 1 CARTONTABLET, COATED13
63868-570-50Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, COATED503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-570-01EA - Each63868-5701463faf7-74de-401c-a86b-568e6a8172da12022-10-06
63868-570-50EA - Each63868-5707074b208-0893-453d-a8cf-0e38584a9be312022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-570IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2Current NDC, Legacy NDC, 4 package rows20200830_9c1ded4e-1d3b-1ab6-e053-2995a90aa80d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN9c1ded4e-1d3b-1ab6-e053-2995a90aa80d3
310965ibuprofen 200 MG Oral TabletSCD9c1ded4e-1d3b-1ab6-e053-2995a90aa80d3
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY9c1ded4e-1d3b-1ab6-e053-2995a90aa80d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-570-01638680570011 BOTTLE, PLASTIC in 1 CARTON (63868-570-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2020-05-152027-04-30NoNoCurrent
63868-570-50638680570501 BOTTLE, PLASTIC in 1 CARTON (63868-570-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2020-03-252026-10-31NoNoCurrent