FDA.reportPublic FDA data

Ibuprofen

Product NDC
16103-407
11-digit product format
161030407
Labeler code
16103
Product ID
16103-407_f37e5e1c-e147-4719-85fb-dedddb00e8e6
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pharbest Pharmaceuticals, Inc.
Application
ANDA075010
Marketing category
ANDA
Marketing start
2018-10-01
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16103-407-062022-01-28C16284748780-1d6a99b39-5011-a426-e053-dadaa90af4c2Drug Facts
16103-407-082022-01-28C16284748780-1d6a99b39-5011-a426-e053-dadaa90af4c2Drug Facts
16103-407-112022-01-28C16284748780-1d6a99b39-5011-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-407-06Ibuprofen1 in 1 CARTONTABLET, FILM COATED11
16103-407-06Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED501
16103-407-08Ibuprofen1 in 1 CARTONTABLET, FILM COATED11
16103-407-08Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
16103-407-11Ibuprofen1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-407IBUPROFEN TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]1Legacy NDC, 5 package rows20190328_ec19af1f-59a5-4f86-9b53-e0511df30a62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN2b2e3dcb-379a-44f2-9a46-77173a80c47a3
310965ibuprofen 200 MG Oral TabletSCD2b2e3dcb-379a-44f2-9a46-77173a80c47a3
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY2b2e3dcb-379a-44f2-9a46-77173a80c47a3
310965ibuprofen 200 MG Oral TabletPSNda8b0cfb-2c48-47fa-a7c5-d11244dce1e01
310965ibuprofen 200 MG Oral TabletPSNec19af1f-59a5-4f86-9b53-e0511df30a621
310965ibuprofen 200 MG Oral TabletSCDda8b0cfb-2c48-47fa-a7c5-d11244dce1e01
310965ibuprofen 200 MG Oral TabletSCDec19af1f-59a5-4f86-9b53-e0511df30a621
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYda8b0cfb-2c48-47fa-a7c5-d11244dce1e01
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYec19af1f-59a5-4f86-9b53-e0511df30a621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16103-407-06161030407061 BOTTLE, PLASTIC in 1 CARTON (16103-407-06) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2018-10-010000-00-00NoNoCurrent
16103-407-08161030407081 BOTTLE, PLASTIC in 1 CARTON (16103-407-08) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2018-10-010000-00-00NoNoCurrent
16103-407-11161030407111000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16103-407-11) 2018-10-010000-00-00NoNoCurrent