FDA.reportPublic FDA data

OZOBAX

Product NDC
69528-302
11-digit product format
695280302
Labeler code
69528
Product ID
69528-302_4ce95252-8c9b-2246-e063-6294a90a8b25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
SOLUTION
Route
ORAL
Labeler
Rosemont Pharmaceuticals LLC
Application
NDA208193
Marketing category
NDA
Marketing start
2023-10-12
Substance
BACLOFEN
Active strength
10 mg/5mL
Pharmacologic classes
GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OZOBAX
Brand name suffix
DS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN10 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui2667941, 2667943

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e25d01b-2e92-4765-bec7-8a0fd7bdc346Product name220251208
1b1393e5-f2d8-42f5-a070-e3416d619667Product name120250804
88583480-702d-4dfe-a31c-9c00abd818f8Product name720250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83dProduct name220240703
6e532d1f-e0b5-46eb-a2be-d70bd338df9dProduct name120220613
ef6bc0bf-8134-f06b-70d9-4980df6f808eProduct name520210615
eeec0918-7a2f-44bf-83d6-1216e507adbfProduct name320191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75Product name120190611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69528-302-08OZOBAXDS237 mL in 1 BOTTLESOLUTION2372
69528-302-16OZOBAXDS473 mL in 1 BOTTLESOLUTION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69528-302-16ML - Milliliter69528-3028a13f840-0ff5-42eb-91c3-02628e97fa9812024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69528-302OZOBAX DS (BACLOFEN) SOLUTION [METACEL PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20231019_d8ddcec5-debe-42b4-a803-e65917cc6a54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2667941baclofen 10 MG in 5 mL Oral SolutionPSNd8ddcec5-debe-42b4-a803-e65917cc6a542
2667943OZOBAX DS 10 MG in 5 mL Oral SolutionPSNd8ddcec5-debe-42b4-a803-e65917cc6a542
2667943baclofen 2 MG/ML Oral Solution [Ozobax]SBDd8ddcec5-debe-42b4-a803-e65917cc6a542
2667941baclofen 2 MG/ML Oral SolutionSCDd8ddcec5-debe-42b4-a803-e65917cc6a542
2667941baclofen 10 MG per 5 mL Oral SolutionSYd8ddcec5-debe-42b4-a803-e65917cc6a542
2667943Ozobax DS 10 MG per 5 mL Oral SolutionSYd8ddcec5-debe-42b4-a803-e65917cc6a542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69528-302-0869528030208237 mL in 1 BOTTLE (69528-302-08) 237 ml2023-10-12NoNoCurrent
69528-302-1669528030216473 mL in 1 BOTTLE (69528-302-16) 473 ml2023-10-12NoNoCurrent