FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
0363-0748
11-digit product format
003630748
Labeler code
0363
Product ID
0363-0748_ac195bf0-7d3d-464b-8170-fdf63f1cc21b
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Walgreens
Application
ANDA208363
Marketing category
ANDA
Marketing start
2018-04-01
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
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
Rxcui1112231

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0748-08Naproxen Sodium1 in 1 BOXCAPSULE, LIQUID FILLED110
0363-0748-08Naproxen Sodium80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED8010
0363-0748-12Naproxen Sodium120 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED12010
0363-0748-12Naproxen Sodium1 in 1 BOXCAPSULE, LIQUID FILLED110
0363-0748-18Naproxen Sodium180 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED18010
0363-0748-20Naproxen Sodium20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2010
0363-0748-20Naproxen Sodium1 in 1 BOXCAPSULE, LIQUID FILLED110
0363-0748-40Naproxen Sodium40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED4010
0363-0748-40Naproxen Sodium1 in 1 BOXCAPSULE, LIQUID FILLED110
0363-0748-50Naproxen Sodium50 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED5010
0363-0748-50Naproxen Sodium1 in 1 BOXCAPSULE, LIQUID FILLED110
0363-0748-80Naproxen Sodium80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED8010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0748NAPROXEN SODIUM CAPSULE, LIQUID FILLED [WALGREENS]9Current NDC, Legacy NDC, 12 package rows20230916_d9806ad8-1cea-4599-97ef-a956ec7f0e21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1112231naproxen sodium 220 MG Oral CapsulePSNd9806ad8-1cea-4599-97ef-a956ec7f0e2110
1112231naproxen sodium 220 MG Oral CapsuleSCDd9806ad8-1cea-4599-97ef-a956ec7f0e2110
1112231naproxen sodium 220 MG (as naproxen 200 MG) Oral CapsuleSYd9806ad8-1cea-4599-97ef-a956ec7f0e2110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0748-08003630748081 BOTTLE, PLASTIC in 1 BOX (0363-0748-08) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-04-010000-00-00NoNoCurrent
0363-0748-12003630748121 BOTTLE, PLASTIC in 1 BOX (0363-0748-12) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-04-010000-00-00NoNoCurrent
0363-0748-1800363074818180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-0748-18) 2018-04-010000-00-00NoNoCurrent
0363-0748-20003630748201 BOTTLE, PLASTIC in 1 BOX (0363-0748-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-04-010000-00-00NoNoCurrent
0363-0748-40003630748401 BOTTLE, PLASTIC in 1 BOX (0363-0748-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-04-010000-00-00NoNoCurrent
0363-0748-50003630748501 BOTTLE, PLASTIC in 1 BOX (0363-0748-50) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-04-010000-00-00NoNoCurrent
0363-0748-800036307488080 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-0748-80) 2018-04-010000-00-00NoNoCurrent