FDA.reportPublic FDA data

Naprelan

Product NDC
24979-249
11-digit product format
249790249
Labeler code
24979
Product ID
24979-249_1ae3fb8f-0340-45e5-9f71-fe284c0a6037
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
Marketing start
2025-12-31
Substance
NAPROXEN SODIUM
Active strength
375 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
Naprelan
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui1116320, 1116331, 1116339, 1116341, 1116349, 1116351

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
24979-249-01Naprelan100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116331NAPRELAN 375 MG 24HR Extended Release Oral TabletPSNb8a51c9a-488e-4377-a041-436f6a2f88932
1116341NAPRELAN 500 MG 24HR Extended Release Oral TabletPSNb8a51c9a-488e-4377-a041-436f6a2f88932
1116351NAPRELAN 750 MG 24HR Extended Release Oral TabletPSNb8a51c9a-488e-4377-a041-436f6a2f88932
1116320naproxen sodium 375 MG 24HR Extended Release Oral TabletPSNb8a51c9a-488e-4377-a041-436f6a2f88932
1116339naproxen sodium 500 MG 24HR Extended Release Oral TabletPSNb8a51c9a-488e-4377-a041-436f6a2f88932
1116349naproxen sodium 750 MG 24HR Extended Release Oral TabletPSNb8a51c9a-488e-4377-a041-436f6a2f88932
111633124 HR naproxen 375 MG Extended Release Oral Tablet [Naprelan]SBDb8a51c9a-488e-4377-a041-436f6a2f88932
111634124 HR naproxen 500 MG Extended Release Oral Tablet [Naprelan]SBDb8a51c9a-488e-4377-a041-436f6a2f88932
111635124 HR naproxen 750 MG Extended Release Oral Tablet [Naprelan]SBDb8a51c9a-488e-4377-a041-436f6a2f88932
111632024 HR naproxen 375 MG Extended Release Oral TabletSCDb8a51c9a-488e-4377-a041-436f6a2f88932
111633924 HR naproxen 500 MG Extended Release Oral TabletSCDb8a51c9a-488e-4377-a041-436f6a2f88932
111634924 HR naproxen 750 MG Extended Release Oral TabletSCDb8a51c9a-488e-4377-a041-436f6a2f88932
111633124 HR Naprelan 375 MG Extended Release Oral TabletSYb8a51c9a-488e-4377-a041-436f6a2f88932
111634124 HR Naprelan 500 MG Extended Release Oral TabletSYb8a51c9a-488e-4377-a041-436f6a2f88932
111635124 HR Naprelan 750 MG Extended Release Oral TabletSYb8a51c9a-488e-4377-a041-436f6a2f88932
1116331Naprelan 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral TabletSYb8a51c9a-488e-4377-a041-436f6a2f88932
1116341Naprelan 500 MG (naproxen sodium 550 MG) 24 HR Extended Release Oral TabletSYb8a51c9a-488e-4377-a041-436f6a2f88932
1116351Naprelan 750 MG (naproxen sodium 825 MG) 24 HR Extended Release Oral TabletSYb8a51c9a-488e-4377-a041-436f6a2f88932
1116320naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral TabletSYb8a51c9a-488e-4377-a041-436f6a2f88932
1116339naproxen 500 MG (naproxen sodium 550 MG) 24 HR Extended Release Oral TabletSYb8a51c9a-488e-4377-a041-436f6a2f88932
1116349naproxen 750 MG (as naproxen sodium 825 MG) 24 HR Extended Release Oral TabletSYb8a51c9a-488e-4377-a041-436f6a2f88932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24979-249-0124979024901100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-249-01) 2025-12-31NoNoCurrent