Naproxen

Product NDC
55700-888
11-digit product format
557000888
Labeler code
55700
Product ID
55700-888_6833d58c-6eef-40ff-b484-e325ce1d133d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA212517
Marketing category
ANDA
Marketing start
2021-02-26
Marketing end
2027-05-31
Substance
NAPROXEN
Active strength
500 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198014

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
55700-888-20Naproxen20 in 1 BOTTLETABLET205
55700-888-30Naproxen30 in 1 BOTTLETABLET305
55700-888-60Naproxen60 in 1 BOTTLETABLET605
55700-888-90Naproxen90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-888NAPROXEN TABLET [QUALITY CARE PRODUCTS, LLC]5Current NDC, Legacy NDC, 4 package rows20241220_1acfb8cc-6faf-4b3e-9304-4819c42de0a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSN1acfb8cc-6faf-4b3e-9304-4819c42de0a65
198014naproxen 500 MG Oral TabletSCD1acfb8cc-6faf-4b3e-9304-4819c42de0a65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-888-205570008882020 TABLET in 1 BOTTLE (55700-888-20) 20 tablet2021-02-260000-00-00NoNoCurrent
55700-888-305570008883030 TABLET in 1 BOTTLE (55700-888-30) 30 tablet2021-02-262027-05-31NoNoCurrent
55700-888-605570008886060 TABLET in 1 BOTTLE (55700-888-60) 60 tablet2021-02-262027-05-31NoNoCurrent
55700-888-905570008889090 TABLET in 1 BOTTLE (55700-888-90) 90 tablet2021-02-260000-00-00NoNoCurrent