FDA.reportPublic FDA data

Ibuprofen

Product NDC
72036-109
11-digit product format
720360109
Labeler code
72036
Product ID
72036-109_3597266a-314f-53db-e063-6394a90ac2da
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Harris Teeter
Application
ANDA079174
Marketing category
ANDA
Marketing start
2012-07-23
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
Ibuprofen
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
72036-109-01Ibuprofen1 in 1 CARTONTABLET, COATED15
72036-109-01Ibuprofen24 in 1 BOTTLE, PLASTICTABLET, COATED245
72036-109-02Ibuprofen1 in 1 CARTONTABLET, COATED15
72036-109-02Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, COATED505
72036-109-03Ibuprofen1 in 1 CARTONTABLET, COATED15
72036-109-03Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, COATED1005
72036-109-05Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, COATED5005
72036-109-08Ibuprofen300 in 1 BOTTLE, PLASTICTABLET, COATED3005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72036-109IBUPROFEN TABLET, COATED [HARRIS TEETER]5Current NDC, Legacy NDC, 8 package rows20250523_1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc633.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc6335
310965ibuprofen 200 MG Oral TabletSCD1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc6335
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc6335

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72036-109-01720360109011 BOTTLE, PLASTIC in 1 CARTON (72036-109-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2012-07-230000-00-00NoNoCurrent
72036-109-02720360109021 BOTTLE, PLASTIC in 1 CARTON (72036-109-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2012-07-230000-00-00NoNoCurrent
72036-109-03720360109031 BOTTLE, PLASTIC in 1 CARTON (72036-109-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2012-07-230000-00-00NoNoCurrent
72036-109-0572036010905500 TABLET, COATED in 1 BOTTLE, PLASTIC (72036-109-05) 2012-08-090000-00-00NoNoCurrent
72036-109-0872036010908300 TABLET, COATED in 1 BOTTLE, PLASTIC (72036-109-08) 2012-08-220000-00-00NoNoCurrent