FDA.reportPublic FDA data

Naproxen

Product NDC
43063-600
11-digit product format
430630600
Labeler code
43063
Product ID
43063-600_39f936c5-d0d1-6804-e063-6394a90add94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA075927
Marketing category
ANDA
Marketing start
2010-02-18
Substance
NAPROXEN
Active strength
250 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198013

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
43063-600-06Naproxen6 in 1 BOTTLE, PLASTICTABLET625
43063-600-15Naproxen15 in 1 BOTTLE, PLASTICTABLET1525
43063-600-20Naproxen20 in 1 BOTTLE, PLASTICTABLET2025
43063-600-30Naproxen30 in 1 BOTTLE, PLASTICTABLET3025
43063-600-60Naproxen60 in 1 BOTTLE, PLASTICTABLET6025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-600-06EA - Each43063-600e9266bc6-795c-4fe6-b7e6-870fd97ac16b12016-03-04
43063-600-15EA - Each43063-60051688a5b-99fa-4455-8c6e-ed928efa653f12015-10-02
43063-600-20EA - Each43063-6007f8dacc4-c691-4c4d-b6b8-4b4c6722328f12015-10-02
43063-600-30EA - Each43063-600d7d359d6-dbdb-48f6-bb88-631c2f173b0b12015-10-02
43063-600-60EA - Each43063-6002c26d6f3-8cef-447a-bcd8-9922e9d7034012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]10
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]10
POVIDONESINACTIVE INGREDIENTFZ989GH94ENAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-600NAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 5 package rows20241013_6573681e-e9be-440f-a818-a533b744648e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198013naproxen 250 MG Oral TabletPSN6573681e-e9be-440f-a818-a533b744648e25
198013naproxen 250 MG Oral TabletSCD6573681e-e9be-440f-a818-a533b744648e25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-600-06430630600066 TABLET in 1 BOTTLE, PLASTIC (43063-600-06) 6 tablet2015-08-260000-00-00NoNoCurrent
43063-600-154306306001515 TABLET in 1 BOTTLE, PLASTIC (43063-600-15) 15 tablet2015-08-260000-00-00NoNoCurrent
43063-600-204306306002020 TABLET in 1 BOTTLE, PLASTIC (43063-600-20) 20 tablet2015-08-260000-00-00NoNoCurrent
43063-600-304306306003030 TABLET in 1 BOTTLE, PLASTIC (43063-600-30) 30 tablet2015-08-260000-00-00NoNoCurrent
43063-600-604306306006060 TABLET in 1 BOTTLE, PLASTIC (43063-600-60) 60 tablet2015-08-260000-00-00NoNoCurrent