FDA.reportPublic FDA data

Nabumetone

Product NDC
55700-840
11-digit product format
557000840
Labeler code
55700
Product ID
55700-840_1c410e1f-a7e6-4dc8-aa58-a31ee965a5b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA078420
Marketing category
ANDA
Marketing start
2019-06-26
Marketing end
2027-05-31
Substance
NABUMETONE
Active strength
750 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nabumetone

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NABUMETONE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLW0TIW155Z
Rxcui311893

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9d4d18c4-d38e-37e1-df1c-ee38762bf8a5Product name420251024

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55700-840-30Nabumetone30 in 1 BOTTLETABLET305
55700-840-60Nabumetone60 in 1 BOTTLETABLET605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-840-30EA - Each55700-840b76e3b86-ea3d-46ba-a4fd-622edbbe81bc12020-03-10
55700-840-60EA - Each55700-840cfccdbc7-4c6e-4492-8fdb-b6068323ba5b12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-840NABUMETONE TABLET [QUALITY CARE PRODUCTS, LLC]5Current NDC, Legacy NDC, 2 package rows20241220_da259c7c-6f1e-403c-b42b-596d53b61fe5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311893nabumetone 750 MG Oral TabletPSNda259c7c-6f1e-403c-b42b-596d53b61fe55
311893nabumetone 750 MG Oral TabletSCDda259c7c-6f1e-403c-b42b-596d53b61fe55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-840-305570008403030 TABLET in 1 BOTTLE (55700-840-30) 30 tablet2020-01-240000-00-00NoNoCurrent
55700-840-605570008406060 TABLET in 1 BOTTLE (55700-840-60) 60 tablet2020-01-242027-05-31NoNoCurrent