FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
24979-254
11-digit product format
249790254
Labeler code
24979
Product ID
24979-254_a79a3bf0-fe2f-4ba4-8eaa-e1c97ab9b927
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
NDA020353
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-04-25
Substance
NAPROXEN SODIUM
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui1116320, 1116339, 1116349

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
24979-254-06Naproxen Sodium30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-254-06EA - Each24979-25431ac53c4-63a1-4833-b261-6dec8fda50f612024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-254NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC]2Current NDC, 1 package rows20241127_7c22a2d6-821c-4f83-aead-e756aed930e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116320naproxen sodium 375 MG 24HR Extended Release Oral TabletPSN7c22a2d6-821c-4f83-aead-e756aed930e53
1116339naproxen sodium 500 MG 24HR Extended Release Oral TabletPSN7c22a2d6-821c-4f83-aead-e756aed930e53
1116349naproxen sodium 750 MG 24HR Extended Release Oral TabletPSN7c22a2d6-821c-4f83-aead-e756aed930e53
111632024 HR naproxen 375 MG Extended Release Oral TabletSCD7c22a2d6-821c-4f83-aead-e756aed930e53
111633924 HR naproxen 500 MG Extended Release Oral TabletSCD7c22a2d6-821c-4f83-aead-e756aed930e53
111634924 HR naproxen 750 MG Extended Release Oral TabletSCD7c22a2d6-821c-4f83-aead-e756aed930e53
1116320naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral TabletSY7c22a2d6-821c-4f83-aead-e756aed930e53
1116339naproxen 500 MG (naproxen sodium 550 MG) 24 HR Extended Release Oral TabletSY7c22a2d6-821c-4f83-aead-e756aed930e53
1116349naproxen 750 MG (as naproxen sodium 825 MG) 24 HR Extended Release Oral TabletSY7c22a2d6-821c-4f83-aead-e756aed930e53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24979-254-062497902540630 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-254-06) 2024-04-25NoNoCurrent