FDA.reportPublic FDA data

Naproxen

Product NDC
46122-564
11-digit product format
461220564
Labeler code
46122
Product ID
46122-564_df535323-45f6-489b-81fe-009ca024499d
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amerisource Bergen
Application
ANDA204872
Marketing category
ANDA
Marketing start
2019-02-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen
Listing expiration
2026-12-31

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
46122-564-71Naproxen1 in 1 CARTONTABLET, FILM COATED110
46122-564-71Naproxen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5010
46122-564-78Naproxen1 in 1 CARTONTABLET, FILM COATED110
46122-564-78Naproxen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10010
46122-564-81Naproxen200 in 1 BOTTLE, PLASTICTABLET, FILM COATED20010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-564-71EA - Each46122-564265b3974-847f-40ae-b1b9-a1756317e1d012019-07-02
46122-564-78EA - Each46122-5640aae3b79-1454-41ff-9dd6-b0b793fd0b1a12019-07-02
46122-564-81EA - Each46122-5644bf2fc57-bebe-4dcc-8a1d-7dde4fcaba6412019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-564NAPROXEN (NAPROXEN SODIUM) TABLET, FILM COATED [AMERISOURCE BERGEN]9Current NDC, Legacy NDC, 5 package rows20241108_1e2e6e3a-b095-4d5b-86fe-61eb44a87cf0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN1e2e6e3a-b095-4d5b-86fe-61eb44a87cf010
849574naproxen sodium 220 MG Oral TabletSCD1e2e6e3a-b095-4d5b-86fe-61eb44a87cf010
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY1e2e6e3a-b095-4d5b-86fe-61eb44a87cf010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-564-71461220564711 BOTTLE, PLASTIC in 1 CARTON (46122-564-71) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2019-02-010000-00-00NoNoCurrent
46122-564-78461220564781 BOTTLE, PLASTIC in 1 CARTON (46122-564-78) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2019-02-010000-00-00NoNoCurrent
46122-564-8146122056481200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46122-564-81) 2019-02-010000-00-00NoNoCurrent