FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
42507-245
11-digit product format
425070245
Labeler code
42507
Product ID
42507-245_484bfd9d-d3cf-09f0-e063-6394a90a5eb1
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN SODIUM
Dosage form
TABLET, COATED
Route
ORAL
Labeler
HYVEE INC
Application
ANDA079096
Marketing category
ANDA
Marketing start
2026-01-13
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
Naproxen Sodium
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
42507-245-01Naproxen Sodium1 in 1 CARTONTABLET, COATED12
42507-245-01Naproxen Sodium24 in 1 BOTTLE, PLASTICTABLET, COATED242
42507-245-14Naproxen Sodium1 in 1 CARTONTABLET, COATED12
42507-245-14Naproxen Sodium90 in 1 BOTTLE, PLASTICTABLET, COATED902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN45a0c910-7dd7-6a42-e063-6394a90a491c2
849574naproxen sodium 220 MG Oral TabletSCD45a0c910-7dd7-6a42-e063-6394a90a491c2
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY45a0c910-7dd7-6a42-e063-6394a90a491c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42507-245-01425070245011 BOTTLE, PLASTIC in 1 CARTON (42507-245-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2026-01-13NoNoCurrent
42507-245-14425070245141 BOTTLE, PLASTIC in 1 CARTON (42507-245-14) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC2026-01-13NoNoCurrent