FDA.reportPublic FDA data

Ibuprofen

Product NDC
51655-385
11-digit product format
516550385
Labeler code
51655
Product ID
51655-385_48ebc5ed-d3df-80c1-e063-6294a90ac01a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA091625
Marketing category
ANDA
Marketing start
2020-05-21
Substance
IBUPROFEN
Active strength
800 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197807

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
51655-385-212023-03-20C16284748780-1f386c64a-48f3-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
51655-385-512023-03-20C16284748780-1f386c64a-48f3-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
51655-385-522023-03-20C16284748780-1f386c64a-48f3-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
51655-385-212023-01-30C16284748780-1f386c64a-48f3-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
51655-385-512023-01-30C16284748780-1f386c64a-48f3-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
51655-385-522023-01-30C16284748780-1f386c64a-48f3-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-385-20Ibuprofen20 in 1 BOTTLE, PLASTICTABLET, FILM COATED206
51655-385-21Ibuprofen21 in 1 BOTTLE, PLASTICTABLET, FILM COATED216
51655-385-25Ibuprofen60 in 1 BOTTLE, PLASTICTABLET, FILM COATED606
51655-385-26Ibuprofen90 in 1 BOTTLE, PLASTICTABLET, FILM COATED906
51655-385-51Ibuprofen40 in 1 BOTTLE, PLASTICTABLET, FILM COATED406
51655-385-52Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306
51655-385-54Ibuprofen15 in 1 BOTTLE, PLASTICTABLET, FILM COATED156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-385IBUPROFEN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 7 package rows20240720_ab80abe6-f7db-479b-e053-2a95a90a90e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSNab80abe6-f7db-479b-e053-2a95a90a90e36
197807ibuprofen 800 MG Oral TabletSCDab80abe6-f7db-479b-e053-2a95a90a90e36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-385-205165503852020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-385-20) 2023-02-20NoNoCurrent
51655-385-215165503852121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-385-21) 2020-05-210000-00-00NoNoCurrent
51655-385-255165503852560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-385-25) 2023-04-07NoNoCurrent
51655-385-265165503852690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-385-26) 2022-09-08NoNoCurrent
51655-385-515165503855140 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-385-51) 2020-05-210000-00-00NoNoCurrent
51655-385-525165503855230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-385-52) 2020-05-210000-00-00NoNoCurrent
51655-385-545165503855415 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-385-54) 2021-05-07NoNoCurrent