FDA.reportPublic FDA data

NAPROXEN

Product NDC
43063-920
11-digit product format
430630920
Labeler code
43063
Product ID
43063-920_415db902-541e-accc-e063-6394a90a54e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NAPROXEN
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA091416
Marketing category
ANDA
Marketing start
2016-07-06
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
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
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
43063-920-04NAPROXEN4 in 1 BOTTLE, PLASTICTABLET422
43063-920-06NAPROXEN6 in 1 BOTTLE, PLASTICTABLET622
43063-920-14NAPROXEN14 in 1 BOTTLE, PLASTICTABLET1422
43063-920-15NAPROXEN15 in 1 BOTTLE, PLASTICTABLET1522
43063-920-20NAPROXEN20 in 1 BOTTLE, PLASTICTABLET2022
43063-920-28NAPROXEN28 in 1 BOTTLE, PLASTICTABLET2822
43063-920-30NAPROXEN30 in 1 BOTTLE, PLASTICTABLET3022
43063-920-60NAPROXEN60 in 1 BOTTLE, PLASTICTABLET6022
43063-920-90NAPROXEN90 in 1 BOTTLE, PLASTICTABLET9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-920-04EA - Each43063-920cb295f30-4a25-4db2-bf52-d163c60ea02112019-02-13
43063-920-06EA - Each43063-920b5931e6f-df19-4466-9ad0-3c185843311412019-07-02
43063-920-14EA - Each43063-9203be058d1-7615-4d3a-80eb-4a6609dc774412019-04-11
43063-920-15EA - Each43063-920c2a60adb-af1d-4fa7-b2f2-953a2b2f995312019-02-13
43063-920-20EA - Each43063-920ab8507c6-5e65-44a1-80e0-ec89612232e112019-03-12
43063-920-28EA - Each43063-9203648ee42-8dd1-4b3b-9fc0-84ac556b82b112019-11-12
43063-920-30EA - Each43063-92032c71724-09c8-44a3-af79-677a05361afc12019-02-13
43063-920-60EA - Each43063-920b78ccd68-ce24-4e76-9f6d-ad242a032de712019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-920NAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 9 package rows20241018_a9f9ce81-9d51-4167-9581-974866a8fe31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNa9f9ce81-9d51-4167-9581-974866a8fe3122
198014naproxen 500 MG Oral TabletSCDa9f9ce81-9d51-4167-9581-974866a8fe3122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-920-04430630920044 TABLET in 1 BOTTLE, PLASTIC (43063-920-04) 4 tablet2018-12-180000-00-00NoNoCurrent
43063-920-06430630920066 TABLET in 1 BOTTLE, PLASTIC (43063-920-06) 6 tablet2019-05-310000-00-00NoNoCurrent
43063-920-144306309201414 TABLET in 1 BOTTLE, PLASTIC (43063-920-14) 14 tablet2019-02-080000-00-00NoNoCurrent
43063-920-154306309201515 TABLET in 1 BOTTLE, PLASTIC (43063-920-15) 15 tablet2019-01-160000-00-00NoNoCurrent
43063-920-204306309202020 TABLET in 1 BOTTLE, PLASTIC (43063-920-20) 20 tablet2019-02-070000-00-00NoNoCurrent
43063-920-284306309202828 TABLET in 1 BOTTLE, PLASTIC (43063-920-28) 28 tablet2019-09-240000-00-00NoNoCurrent
43063-920-304306309203030 TABLET in 1 BOTTLE, PLASTIC (43063-920-30) 30 tablet2019-01-140000-00-00NoNoCurrent
43063-920-604306309206060 TABLET in 1 BOTTLE, PLASTIC (43063-920-60) 60 tablet2019-02-180000-00-00NoNoCurrent
43063-920-904306309209090 TABLET in 1 BOTTLE, PLASTIC (43063-920-90) 90 tablet2020-09-010000-00-00NoNoCurrent