FDA.reportPublic FDA data

Ibuprofen

Product NDC
16103-396
11-digit product format
161030396
Labeler code
16103
Product ID
16103-396_b930519b-3c6f-4f19-8e84-227c44b06331
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Pharbest Pharmaceuticals, Inc.
Application
ANDA091239
Marketing category
ANDA
Marketing start
2016-03-01
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16103-396-042022-01-28C16284748780-1d6a99b39-4ed2-a426-e053-dadaa90af4c2Drug Facts
16103-396-062022-01-28C16284748780-1d6a99b39-4ed2-a426-e053-dadaa90af4c2Drug Facts
16103-396-082022-01-28C16284748780-1d6a99b39-4ed2-a426-e053-dadaa90af4c2Drug Facts
16103-396-112022-01-28C16284748780-1d6a99b39-4ed2-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-396-04Ibuprofen1 in 1 CARTONTABLET11
16103-396-04Ibuprofen30 in 1 BOTTLE, PLASTICTABLET301
16103-396-06Ibuprofen1 in 1 CARTONTABLET11
16103-396-06Ibuprofen50 in 1 BOTTLE, PLASTICTABLET501
16103-396-08Ibuprofen1 in 1 CARTONTABLET11
16103-396-08Ibuprofen100 in 1 BOTTLE, PLASTICTABLET1001
16103-396-11Ibuprofen1000 in 1 BOTTLE, PLASTICTABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-396IBUPROFEN TABLET [PHARBEST PHARMACEUTICALS, INC.]1Legacy NDC, 7 package rows20180520_5ebcd4d3-0397-4061-be0f-7e50b9d1780d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN5ebcd4d3-0397-4061-be0f-7e50b9d1780d1
310965ibuprofen 200 MG Oral TabletPSN994cb67c-d77d-4319-a4ee-6c4d239ce6c31
310965ibuprofen 200 MG Oral TabletPSNb933a883-713b-47f0-9666-841359c661981
310965ibuprofen 200 MG Oral TabletSCD5ebcd4d3-0397-4061-be0f-7e50b9d1780d1
310965ibuprofen 200 MG Oral TabletSCD994cb67c-d77d-4319-a4ee-6c4d239ce6c31
310965ibuprofen 200 MG Oral TabletSCDb933a883-713b-47f0-9666-841359c661981
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY5ebcd4d3-0397-4061-be0f-7e50b9d1780d1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY994cb67c-d77d-4319-a4ee-6c4d239ce6c31
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYb933a883-713b-47f0-9666-841359c661981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16103-396-04161030396041 BOTTLE, PLASTIC in 1 CARTON (16103-396-04) > 30 TABLET in 1 BOTTLE, PLASTIC2016-03-010000-00-00NoNoCurrent
16103-396-06161030396061 BOTTLE, PLASTIC in 1 CARTON (16103-396-06) > 50 TABLET in 1 BOTTLE, PLASTIC2016-03-010000-00-00NoNoCurrent
16103-396-08161030396081 BOTTLE, PLASTIC in 1 CARTON (16103-396-08) > 100 TABLET in 1 BOTTLE, PLASTIC2016-03-010000-00-00NoNoCurrent
16103-396-11161030396111000 TABLET in 1 BOTTLE, PLASTIC (16103-396-11) 1000 tablet2016-03-010000-00-00NoNoCurrent