FDA.reportPublic FDA data

Flanax

Product NDC
27854-160
11-digit product format
278540160
Labeler code
27854
Product ID
27854-160_15256b57-2263-447e-9a11-f3f8f7edd6c3
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Belmora LLC
Application
ANDA204872
Marketing category
ANDA
Marketing start
2018-01-15
Substance
NAPROXEN SODIUM
Active strength
220 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Flanax
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27854-160-00Flanax100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10014
27854-160-00Flanax1 in 1 CARTONTABLET, FILM COATED114
27854-160-01Flanax1 in 1 CARTONTABLET, FILM COATED114
27854-160-01Flanax10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1014
27854-160-24Flanax24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2414
27854-160-24Flanax1 in 1 CARTONTABLET, FILM COATED114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27854-160-24EA - Each27854-1606047044f-79dd-4834-8912-ab2e5b59507b12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27854-160FLANAX (NAPROXEN SODIUM) TABLET, FILM COATED [BELMORA LLC]12Current NDC, Legacy NDC, 6 package rows20240825_2c099d45-f03a-4161-a6af-8fe5965f2748.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN2c099d45-f03a-4161-a6af-8fe5965f274814
849574naproxen sodium 220 MG Oral TabletSCD2c099d45-f03a-4161-a6af-8fe5965f274814
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY2c099d45-f03a-4161-a6af-8fe5965f274814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27854-160-00278540160001 BOTTLE, PLASTIC in 1 CARTON (27854-160-00) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC2018-01-150000-00-00NoNoCurrent
27854-160-01278540160011 BOTTLE, PLASTIC in 1 CARTON (27854-160-01) / 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2018-01-150000-00-00NoNoCurrent
27854-160-24278540160241 BOTTLE, PLASTIC in 1 CARTON (27854-160-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2018-01-150000-00-00NoNoCurrent