FDA.reportPublic FDA data

signature care naproxen sodium

Product NDC
21130-180
11-digit product format
211300180
Labeler code
21130
Product ID
21130-180_347809fc-ce5e-49ff-b4e5-a36aa9eb6a72
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Safeway
Application
ANDA074661
Marketing category
ANDA
Marketing start
2018-04-03
Marketing end
2027-02-28
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
signature care naproxen sodium

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574

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
21130-180-62signature care naproxen sodium1 in 1 CARTONTABLET, FILM COATED16
21130-180-62signature care naproxen sodium24 in 1 BOTTLETABLET, FILM COATED246
21130-180-71signature care naproxen sodium1 in 1 CARTONTABLET, FILM COATED16
21130-180-71signature care naproxen sodium50 in 1 BOTTLETABLET, FILM COATED506
21130-180-75signature care naproxen sodium90 in 1 BOTTLETABLET, FILM COATED906
21130-180-75signature care naproxen sodium1 in 1 CARTONTABLET, FILM COATED16
21130-180-78signature care naproxen sodium100 in 1 BOTTLETABLET, FILM COATED1006
21130-180-78signature care naproxen sodium1 in 1 CARTONTABLET, FILM COATED16
21130-180-79signature care naproxen sodium400 in 1 BOTTLETABLET, FILM COATED4006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-180SIGNATURE CARE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [SAFEWAY]5Current NDC, Legacy NDC, 9 package rows20250308_85f78e63-98aa-4cf3-887d-0ac535184f97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN85f78e63-98aa-4cf3-887d-0ac535184f976
849574naproxen sodium 220 MG Oral TabletSCD85f78e63-98aa-4cf3-887d-0ac535184f976
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY85f78e63-98aa-4cf3-887d-0ac535184f976

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-180-62211300180621 BOTTLE in 1 CARTON (21130-180-62) > 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-04-030000-00-00NoNoCurrent
21130-180-71211300180711 BOTTLE in 1 CARTON (21130-180-71) > 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-11-230000-00-00NoNoCurrent
21130-180-75211300180751 BOTTLE in 1 CARTON (21130-180-75) > 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-04-070000-00-00NoNoCurrent
21130-180-78211300180781 BOTTLE in 1 CARTON (21130-180-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-11-230000-00-00NoNoCurrent
21130-180-7921130018079400 TABLET, FILM COATED in 1 BOTTLE (21130-180-79) 2021-11-232027-02-28NoNoCurrent