FDA.reportPublic FDA data

BACK AND MUSCLE PAIN

Product NDC
0363-9609
11-digit product format
003639609
Labeler code
0363
Product ID
0363-9609_4957e6ac-f38a-b51d-e063-6294a90a99c9
Type
HUMAN OTC DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET, COATED
Route
ORAL
Labeler
WALGREENS
Application
ANDA090545
Marketing category
ANDA
Marketing start
2019-06-03
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BACK AND MUSCLE PAIN
Listing expiration
2027-12-31

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
0363-9609-01BACK AND MUSCLE PAIN100 in 1 BOTTLETABLET, COATED1006
0363-9609-09BACK AND MUSCLE PAIN90 in 1 BOTTLETABLET, COATED906
0363-9609-09BACK AND MUSCLE PAIN1 in 1 CARTONTABLET, COATED16
0363-9609-20BACK AND MUSCLE PAIN200 in 1 BOTTLETABLET, COATED2006
0363-9609-42BACK AND MUSCLE PAIN24 in 1 BOTTLETABLET, COATED246

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-9609-01EA - Each0363-960956fe066d-8a59-426f-b6db-af80976a593112022-06-06
0363-9609-42EA - Each0363-9609a045dca8-d714-4dd7-8be7-8d29eef7a33912022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9609BACK AND MUSCLE PAIN (NAPROXEN) TABLET, COATED [WALGREENS]5Current NDC, Legacy NDC, 5 package rows20240316_81417810-8a34-c859-e053-2a91aa0a6507.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN81417810-8a34-c859-e053-2a91aa0a65076
849574naproxen sodium 220 MG Oral TabletSCD81417810-8a34-c859-e053-2a91aa0a65076
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY81417810-8a34-c859-e053-2a91aa0a65076

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9609-0100363960901100 TABLET, COATED in 1 BOTTLE (0363-9609-01) 2019-06-030000-00-00NoNoCurrent
0363-9609-09003639609091 BOTTLE in 1 CARTON (0363-9609-09) / 90 TABLET, COATED in 1 BOTTLE1 bottle2021-06-260000-00-00NoNoCurrent
0363-9609-2000363960920200 TABLET, COATED in 1 BOTTLE (0363-9609-20) 2026-02-01NoNoHistorical
0363-9609-420036396094224 TABLET, COATED in 1 BOTTLE (0363-9609-42) 2019-06-050000-00-00NoNoCurrent