FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
0363-0177
11-digit product format
003630177
Labeler code
0363
Product ID
0363-0177_da638473-feb5-ccf1-e053-2a95a90a80d3
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
WALGREEN COMPANY
Application
NDA021920
Marketing category
NDA
Marketing start
2019-08-02
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 Sodium
Listing expiration
2026-12-31

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0177-11Naproxen Sodium1 in 1 CARTONCAPSULE, LIQUID FILLED14
0363-0177-11Naproxen Sodium20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED204
0363-0177-15Naproxen Sodium40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED404
0363-0177-15Naproxen Sodium1 in 1 CARTONCAPSULE, LIQUID FILLED14
0363-0177-16Naproxen Sodium50 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED504
0363-0177-16Naproxen Sodium1 in 1 CARTONCAPSULE, LIQUID FILLED14
0363-0177-22Naproxen Sodium1 in 1 CARTONCAPSULE, LIQUID FILLED14
0363-0177-22Naproxen Sodium120 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1204
0363-0177-25Naproxen Sodium180 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1804
0363-0177-78Naproxen Sodium80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED804
0363-0177-78Naproxen Sodium1 in 1 CARTONCAPSULE, LIQUID FILLED14
0363-0177-99Naproxen Sodium80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0177-11EA - Each0363-0177cd9586a1-1e14-4349-8d81-03ee654e8ff012022-06-06
0363-0177-15EA - Each0363-017727fcb231-aeed-4904-be60-b4a7d39adf3912022-06-06
0363-0177-22EA - Each0363-0177abe59a34-5b15-4e10-bf08-9d0a5e5e0f4212022-06-06
0363-0177-78EA - Each0363-017731b50ba8-f8b6-4251-bbb2-0dc6dd04a8af12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0177NAPROXEN SODIUM CAPSULE, LIQUID FILLED [WALGREEN COMPANY]4Current NDC, Legacy NDC, 12 package rows20220520_462a7e41-b899-4e08-8113-b48ece0ad8d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1112231naproxen sodium 220 MG Oral CapsulePSN462a7e41-b899-4e08-8113-b48ece0ad8d84
1112231naproxen sodium 220 MG Oral CapsuleSCD462a7e41-b899-4e08-8113-b48ece0ad8d84
1112231naproxen sodium 220 MG (as naproxen 200 MG) Oral CapsuleSY462a7e41-b899-4e08-8113-b48ece0ad8d84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0177-11003630177111 BOTTLE, PLASTIC in 1 CARTON (0363-0177-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2019-08-020000-00-00NoNoCurrent
0363-0177-15003630177151 BOTTLE, PLASTIC in 1 CARTON (0363-0177-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2019-08-020000-00-00NoNoCurrent
0363-0177-16003630177161 BOTTLE, PLASTIC in 1 CARTON (0363-0177-16) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2020-04-300000-00-00NoNoCurrent
0363-0177-22003630177221 BOTTLE, PLASTIC in 1 CARTON (0363-0177-22) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2019-08-020000-00-00NoNoCurrent
0363-0177-2500363017725180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-0177-25) 2019-08-020000-00-00NoNoCurrent
0363-0177-78003630177781 BOTTLE, PLASTIC in 1 CARTON (0363-0177-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2019-08-020000-00-00NoNoCurrent
0363-0177-990036301779980 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-0177-99) 2019-08-020000-00-00NoNoCurrent