FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
69452-179
11-digit product format
694520179
Labeler code
69452
Product ID
69452-179_0d85dc59-4954-47fc-e063-6394a90a01cd
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bionpharma Inc.
Application
NDA021920
Marketing category
NDA
Marketing start
2018-11-01
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
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
69452-179-11Naproxen Sodium20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED205
69452-179-15Naproxen Sodium40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED405
69452-179-20Naproxen Sodium100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1005
69452-179-22Naproxen Sodium120 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1205
69452-179-78Naproxen Sodium80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED805
69452-179-79Naproxen Sodium160 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-179NAPROXEN SODIUM CAPSULE, LIQUID FILLED [BIONPHARMA INC.]5Current NDC, Legacy NDC, 6 package rows20231228_3e10256f-0a5f-49e4-9518-a72b10490f89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1112231naproxen sodium 220 MG Oral CapsulePSN3e10256f-0a5f-49e4-9518-a72b10490f895
1112231naproxen sodium 220 MG Oral CapsuleSCD3e10256f-0a5f-49e4-9518-a72b10490f895
1112231naproxen sodium 220 MG (as naproxen 200 MG) Oral CapsuleSY3e10256f-0a5f-49e4-9518-a72b10490f895

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69452-179-116945201791120 in 1 BOTTLE, PLASTICHistorical
69452-179-156945201791540 in 1 BOTTLE, PLASTICHistorical
69452-179-2069452017920100 in 1 BOTTLE, PLASTICHistorical
69452-179-2269452017922120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-179-22) 2018-11-010000-00-00NoNoCurrent
69452-179-786945201797880 in 1 BOTTLE, PLASTICHistorical
69452-179-7969452017979160 in 1 BOTTLE, PLASTICHistorical