FDA.reportPublic FDA data

McKesson Ibuprofen 200 mg

Product NDC
68599-8051
11-digit product format
685998051
Labeler code
68599
Product ID
68599-8051_3e5d8724-abf9-7da2-e063-6294a90a6455
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
McKesson Medical-Surgical
Application
ANDA079174
Marketing category
ANDA
Marketing start
2021-09-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
McKesson Ibuprofen 200 mg
Listing expiration
2026-12-31

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
68599-8051-4McKesson Ibuprofen 200 mg200 in 1 BOXTABLET, COATED2005
68599-8051-4McKesson Ibuprofen 200 mg2 in 1 PACKETTABLET, COATED25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-8051MCKESSON IBUPROFEN 200 MG (IBUPROFEN) TABLET, COATED [MCKESSON MEDICAL-SURGICAL]4Current NDC, Legacy NDC, 2 package rows20241025_ca75b9fe-5bc8-ab90-e053-2995a90a52fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNca75b9fe-5bc8-ab90-e053-2995a90a52fb5
310965ibuprofen 200 MG Oral TabletSCDca75b9fe-5bc8-ab90-e053-2995a90a52fb5
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYca75b9fe-5bc8-ab90-e053-2995a90a52fb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68599-8051-468599805104200 PACKET in 1 BOX (68599-8051-4) / 2 TABLET, COATED in 1 PACKET200 packet2021-09-010000-00-00NoNoCurrent