FDA.reportPublic FDA data

Ibuprofen

Product NDC
37808-699
11-digit product format
378080699
Labeler code
37808
Product ID
37808-699_5c1c8f93-720d-4ae8-bab2-5933f691fff1
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
H E B
Application
ANDA078682
Marketing category
ANDA
Marketing start
2018-03-31
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
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
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
37808-699-202023-02-11C16284748780-1f386c649-b70e-0266-e053-dadaa90a7c1aDrug Facts
37808-699-302023-02-11C16284748780-1f386c649-b70e-0266-e053-dadaa90a7c1aDrug Facts
37808-699-402023-02-11C16284748780-1f386c649-b70e-0266-e053-dadaa90a7c1aDrug Facts
37808-699-802023-02-11C16284748780-1f386c649-b70e-0266-e053-dadaa90a7c1aDrug Facts
37808-699-202023-01-30C16284748780-1f386c649-b70e-0266-e053-dadaa90a7c1aDrug Facts
37808-699-302023-01-30C16284748780-1f386c649-b70e-0266-e053-dadaa90a7c1aDrug Facts
37808-699-402023-01-30C16284748780-1f386c649-b70e-0266-e053-dadaa90a7c1aDrug Facts
37808-699-802023-01-30C16284748780-1f386c649-b70e-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-699-20Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED16
37808-699-20Ibuprofen20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED206
37808-699-30Ibuprofen300 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED3006
37808-699-40Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED16
37808-699-40Ibuprofen40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED406
37808-699-80Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED16
37808-699-80Ibuprofen80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-699IBUPROFEN CAPSULE, LIQUID FILLED [H E B]6Current NDC, Legacy NDC, 7 package rows20241003_2f193146-74b2-4941-893d-3d2f5c8ee659.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN2f193146-74b2-4941-893d-3d2f5c8ee6596
310964ibuprofen 200 MG Oral CapsuleSCD2f193146-74b2-4941-893d-3d2f5c8ee6596

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-699-20378080699201 BOTTLE, PLASTIC in 1 BOX (37808-699-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-03-310000-00-00NoNoCurrent
37808-699-3037808069930300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (37808-699-30) 2018-03-310000-00-00NoNoCurrent
37808-699-40378080699401 BOTTLE, PLASTIC in 1 BOX (37808-699-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-03-310000-00-00NoNoCurrent
37808-699-80378080699801 BOTTLE, PLASTIC in 1 BOX (37808-699-80) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-03-310000-00-00NoNoCurrent