FDA.reportPublic FDA data

Naproxen

Product NDC
43063-650
11-digit product format
430630650
Labeler code
43063
Product ID
43063-650_39f9273f-87db-b615-e063-6294a90a03b6
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
375 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
NAPROXEN375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii57Y76R9ATQ
Rxcui198012

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
43063-650-06Naproxen6 in 1 BOTTLE, PLASTICTABLET629
43063-650-10Naproxen10 in 1 BOTTLE, PLASTICTABLET1029
43063-650-14Naproxen14 in 1 BOTTLE, PLASTICTABLET1429
43063-650-15Naproxen15 in 1 BOTTLE, PLASTICTABLET1529
43063-650-20Naproxen20 in 1 BOTTLE, PLASTICTABLET2029
43063-650-21Naproxen21 in 1 BOTTLE, PLASTICTABLET2129
43063-650-24Naproxen24 in 1 BOTTLE, PLASTICTABLET2429
43063-650-30Naproxen30 in 1 BOTTLE, PLASTICTABLET3029
43063-650-42Naproxen42 in 1 BOTTLE, PLASTICTABLET4229
43063-650-60Naproxen60 in 1 BOTTLE, PLASTICTABLET6029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-650-06EA - Each43063-6509ed33ae0-84dd-4422-97b7-ed9eb824c07812016-03-04
43063-650-10EA - Each43063-65020ef5a02-6e35-48a5-a5d1-173eed09bbe812016-03-04
43063-650-14EA - Each43063-650e0ab2ff6-a743-412e-b07f-31f2875fc1d212016-03-04
43063-650-15EA - Each43063-6506e0ab426-8459-44c4-842e-479836c404e412016-03-04
43063-650-20EA - Each43063-650b2312a49-db76-4e06-abab-cfd50e8d16d212016-03-04
43063-650-21EA - Each43063-6509c4052a1-1198-48f4-ba35-07a68e03a1f712016-03-04
43063-650-24EA - Each43063-65077327ee8-8301-4170-9eae-fd22321cc2ef12016-03-04
43063-650-30EA - Each43063-6505c72e2fd-3e59-4a45-a66b-dc98c23895fa12016-03-04
43063-650-42EA - Each43063-650a434afd1-e6a8-497b-b708-56e49b95bd2412016-03-04
43063-650-60EA - Each43063-6506efe19a6-4dcb-445b-aa04-d87d08f5570312016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-650NAPROXEN TABLET [PD-RX PHARMACEUTICALS, INC.]28Current NDC, Legacy NDC, 10 package rows20250121_29d98cf3-a0f2-3f89-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198012naproxen 375 MG Oral TabletPSN29d98cf3-a0f2-3f89-e054-00144ff88e8829
198012naproxen 375 MG Oral TabletSCD29d98cf3-a0f2-3f89-e054-00144ff88e8829

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-650-06430630650066 TABLET in 1 BOTTLE, PLASTIC (43063-650-06) 6 tablet2016-01-220000-00-00NoNoCurrent
43063-650-104306306501010 TABLET in 1 BOTTLE, PLASTIC (43063-650-10) 10 tablet2016-01-220000-00-00NoNoCurrent
43063-650-144306306501414 TABLET in 1 BOTTLE, PLASTIC (43063-650-14) 14 tablet2016-01-220000-00-00NoNoCurrent
43063-650-154306306501515 TABLET in 1 BOTTLE, PLASTIC (43063-650-15) 15 tablet2016-01-220000-00-00NoNoCurrent
43063-650-204306306502020 TABLET in 1 BOTTLE, PLASTIC (43063-650-20) 20 tablet2016-01-220000-00-00NoNoCurrent
43063-650-214306306502121 TABLET in 1 BOTTLE, PLASTIC (43063-650-21) 21 tablet2016-01-220000-00-00NoNoCurrent
43063-650-244306306502424 TABLET in 1 BOTTLE, PLASTIC (43063-650-24) 24 tablet2016-01-220000-00-00NoNoCurrent
43063-650-304306306503030 TABLET in 1 BOTTLE, PLASTIC (43063-650-30) 30 tablet2016-01-220000-00-00NoNoCurrent
43063-650-424306306504242 TABLET in 1 BOTTLE, PLASTIC (43063-650-42) 42 tablet2016-01-220000-00-00NoNoCurrent
43063-650-604306306506060 TABLET in 1 BOTTLE, PLASTIC (43063-650-60) 60 tablet2016-01-220000-00-00NoNoCurrent