FDA.reportPublic FDA data

Ibuprofen

Product NDC
69842-745
11-digit product format
698420745
Labeler code
69842
Product ID
69842-745_fd1c1135-5d4d-49c9-a23c-2ae92d096ebb
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA206568
Marketing category
ANDA
Marketing start
2018-01-31
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
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
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310964

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-745-022020-09-25C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts
69842-745-162020-09-25C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts
69842-745-202020-09-25C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts
69842-745-302020-09-25C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts
69842-745-402020-09-25C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts
69842-745-482020-09-25C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts
69842-745-502020-09-25C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts
69842-745-602020-09-25C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts
69842-745-802020-09-25C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts
69842-745-022020-07-22C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts
69842-745-162020-07-22C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts
69842-745-202020-07-22C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts
69842-745-302020-07-22C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts
69842-745-402020-07-22C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts
69842-745-482020-07-22C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts
69842-745-502020-07-22C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts
69842-745-602020-07-22C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts
69842-745-802020-07-22C16284748780-1ab0e2407-2ccd-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-745-02Ibuprofen200 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED20019
69842-745-16Ibuprofen160 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED16019
69842-745-16Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED119
69842-745-20Ibuprofen20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2019
69842-745-20Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED119
69842-745-30Ibuprofen300 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED30019
69842-745-40Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED119
69842-745-40Ibuprofen40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED4019
69842-745-48Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED119
69842-745-48Ibuprofen48 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED4819
69842-745-50Ibuprofen500 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED50019
69842-745-60Ibuprofen160 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED16019
69842-745-80Ibuprofen80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED8019
69842-745-88Ibuprofen88 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED8819
69842-745-88Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-745-02EA - Each69842-7451d044c4c-0125-445d-a371-26e5eba9257812022-04-06
69842-745-20EA - Each69842-745898262d7-54e3-4f7a-a36b-60bad18ee6da12024-02-14
69842-745-60EA - Each69842-745e912d946-d294-48f2-a1fe-7d1e8ca6339212022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-745IBUPROFEN CAPSULE, LIQUID FILLED [CVS PHARMACY]18Current NDC, Legacy NDC, 15 package rows20250212_121b13c8-0b1a-4c48-9d57-3b53a9228d34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN121b13c8-0b1a-4c48-9d57-3b53a9228d3419
310964ibuprofen 200 MG Oral CapsuleSCD121b13c8-0b1a-4c48-9d57-3b53a9228d3419

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-745-0269842074502200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-745-02) 2018-01-310000-00-00NoNoCurrent
69842-745-16698420745161 BOTTLE, PLASTIC in 1 BOX (69842-745-16) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-01-310000-00-00NoNoCurrent
69842-745-20698420745201 BOTTLE, PLASTIC in 1 BOX (69842-745-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-01-310000-00-00NoNoCurrent
69842-745-3069842074530300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-745-30) 2018-01-310000-00-00NoNoCurrent
69842-745-40698420745401 BOTTLE, PLASTIC in 1 BOX (69842-745-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-01-310000-00-00NoNoCurrent
69842-745-48698420745481 BOTTLE, PLASTIC in 1 BOX (69842-745-48) / 48 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-01-310000-00-00NoNoCurrent
69842-745-5069842074550500 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-745-50) 2018-01-310000-00-00NoNoCurrent
69842-745-6069842074560160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-745-60) 2018-01-310000-00-00NoNoCurrent
69842-745-806984207458080 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69842-745-80) 2018-01-310000-00-00NoNoCurrent
69842-745-88698420745881 BOTTLE, PLASTIC in 1 BOX (69842-745-88) / 88 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-01-310000-00-00NoNoCurrent