FDA.reportPublic FDA data

Ibuprofen

Product NDC
63868-571
11-digit product format
638680571
Labeler code
63868
Product ID
63868-571_459b4410-1bb3-c1fc-e063-6394a90a08ce
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
2027-02-28
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
63868-571-01Ibuprofen1 in 1 CARTONTABLET, COATED13
63868-571-01Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, COATED1003
63868-571-50Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, COATED503
63868-571-50Ibuprofen1 in 1 CARTONTABLET, COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-571-01EA - Each63868-571584f3b7f-0e49-4c78-a76f-94b9fa65a0fc12022-10-06
63868-571-50EA - Each63868-571b496d7ef-0840-4f31-a11b-ddf813c1357d12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-571IBUPROFEN TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2Current NDC, Legacy NDC, 4 package rows20200830_9c1cc205-b9e3-03fc-e053-2995a90aaffb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN9c1cc205-b9e3-03fc-e053-2995a90aaffb3
310965ibuprofen 200 MG Oral TabletSCD9c1cc205-b9e3-03fc-e053-2995a90aaffb3
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY9c1cc205-b9e3-03fc-e053-2995a90aaffb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-571-01638680571011 BOTTLE, PLASTIC in 1 CARTON (63868-571-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2020-05-152027-02-28NoNoCurrent
63868-571-50638680571501 BOTTLE, PLASTIC in 1 CARTON (63868-571-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2020-03-252027-02-28NoNoCurrent