FDA.reportPublic FDA data

Ibuprofen Oral

Product NDC
69230-310
11-digit product format
692300310
Labeler code
69230
Product ID
69230-310_4dec8846-65f8-d987-e063-6294a90ae5c7
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen Oral
Dosage form
SUSPENSION
Route
ORAL
Labeler
Camber Consumer Care Inc
Application
ANDA210602
Marketing category
ANDA
Marketing start
2019-09-18
Substance
IBUPROFEN
Active strength
100 mg/5mL
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 Oral
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197803

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
69230-310-11Ibuprofen Oral1 in 1 CARTONSUSPENSION14
69230-310-11Ibuprofen Oral118 mL in 1 BOTTLESUSPENSION1184
69230-310-12Ibuprofen Oral1 in 1 CARTONSUSPENSION14
69230-310-12Ibuprofen Oral237 mL in 1 BOTTLESUSPENSION2374

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-310-11ML - Milliliter69230-310141cce7d-44dc-4cb9-a029-c6990c53a66112020-09-14
69230-310-12ML - Milliliter69230-310aa223ecf-8f9a-494e-b54d-3e1f987e0d2712020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-310IBUPROFEN ORAL (IBUPROFEN ORAL) SUSPENSION [CAMBER CONSUMER CARE INC]3Current NDC, Legacy NDC, 4 package rows20220119_b2dd4863-613e-4a41-98c1-3191e41b8463.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN6dc47070-4185-404f-94b0-5252a78ea6fe103
197803ibuprofen 20 MG/ML Oral SuspensionSCD6dc47070-4185-404f-94b0-5252a78ea6fe103
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY6dc47070-4185-404f-94b0-5252a78ea6fe103
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY6dc47070-4185-404f-94b0-5252a78ea6fe103
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN9b98fc28-6cba-4b22-8d4a-9c7735d346b4101
197803ibuprofen 20 MG/ML Oral SuspensionSCD9b98fc28-6cba-4b22-8d4a-9c7735d346b4101
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY9b98fc28-6cba-4b22-8d4a-9c7735d346b4101
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY9b98fc28-6cba-4b22-8d4a-9c7735d346b4101
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNb2dd4863-613e-4a41-98c1-3191e41b84634
197803ibuprofen 20 MG/ML Oral SuspensionSCDb2dd4863-613e-4a41-98c1-3191e41b84634
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYb2dd4863-613e-4a41-98c1-3191e41b84634
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYb2dd4863-613e-4a41-98c1-3191e41b84634

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69230-310-11692300310111 BOTTLE in 1 CARTON (69230-310-11) / 118 mL in 1 BOTTLE1 bottle2019-09-180000-00-00NoNoCurrent
69230-310-12692300310121 BOTTLE in 1 CARTON (69230-310-12) / 237 mL in 1 BOTTLE1 bottle2019-09-180000-00-00NoNoCurrent