FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
59428-784
11-digit product format
594280784
Labeler code
59428
Product ID
59428-784_69001601-2fe8-4621-86ab-53be06d16df7
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Productos Zapotol Corp.
Application
ANDA208363
Marketing category
ANDA
Marketing start
2024-04-30
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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59428-784-20Naproxen Sodium20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED205
59428-784-20Naproxen Sodium1 in 1 BOXCAPSULE, LIQUID FILLED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59428-784NAPROXEN SODIUM CAPSULE, LIQUID FILLED [PRODUCTOS ZAPOTOL CORP.]5Current NDC, 2 package rows20240430_0a69f39e-5eb6-4a98-85f0-87e7449672d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1112231naproxen sodium 220 MG Oral CapsulePSN0a69f39e-5eb6-4a98-85f0-87e7449672d65
1112231naproxen sodium 220 MG Oral CapsuleSCD0a69f39e-5eb6-4a98-85f0-87e7449672d65
1112231naproxen sodium 220 MG (as naproxen 200 MG) Oral CapsuleSY0a69f39e-5eb6-4a98-85f0-87e7449672d65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59428-784-20594280784201 BOTTLE, PLASTIC in 1 BOX (59428-784-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2024-04-30NoNoCurrent