FDA.reportPublic FDA data

Naproxen Sodium

Product NDC
43598-059
11-digit product format
435980059
Labeler code
43598
Product ID
43598-059_7f658fac-fde0-3b5d-f8ad-15dcaf71cdad
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Dr.Reddy's Laboratories Inc
Application
ANDA075168
Marketing category
ANDA
Marketing start
2021-08-05
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075168-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL1998-07-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium
Brand name suffix
Headache Pain Caplets
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9TN87S3A3CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
849574Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
605ca130-88aa-27d5-330c-6d9c95987f1fAvailable on FDA.report

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
43598-059-52Naproxen Sodium Headache Pain Caplets225 in 1 BOTTLETABLET, COATED2256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-059NAPROXEN SODIUM HEADACHE PAIN CAPLETS (NAPROXEN SODIUM) TABLET, COATED NAPROXEN SODIUM BACK AND MUSCLE PAIN CAPLETS (NAPROXEN SODIUM) TABLET, COATED [DR.REDDY'S LABORATORIES INC]5Current NDC, Legacy NDC, 1 package rows20241203_605ca130-88aa-27d5-330c-6d9c95987f1f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen Sodium CapletsNAPROXEN SODIUMDr Reddy's Laboratories Incee0463bc-e939-1ecf-5a86-d045c426fecf2025-07-22WarningsExact identifier
application applno (ANDA): 075168
application number: ANDA075168
Naproxen Sodium Headache Pain CapletsNAPROXEN SODIUMDr.Reddy's Laboratories Inc605ca130-88aa-27d5-330c-6d9c95987f1f2025-07-22WarningsExact identifier
application applno (ANDA): 075168
application number: ANDA075168
ndc (product): 43598-059
Naproxen SodiumNAPROXEN SODIUMSAM'S WEST INC7a87a339-4482-ec9e-3c77-7ccb9cea2c4c2025-07-22WarningsExact identifier
application applno (ANDA): 075168
application number: ANDA075168
Naproxen SodiumNAPROXEN SODIUMKroger Company30bcf289-0039-f389-73c4-fef3e88610342025-07-22WarningsExact identifier
application applno (ANDA): 075168
application number: ANDA075168
Naproxen SodiumNAPROXEN SODIUMDr.Reddy's Laboratories Limitedaca5d497-fbc6-464d-2dee-25c50e11bc782025-06-03WarningsExact identifier
application applno (ANDA): 075168
application number: ANDA075168
Naproxen Sodium Headache PainNAPROXEN SODIUMDr.Reddy's Laboratories Inc12e45b43-eca2-73f4-1d68-07d4238f8c702025-06-03WarningsExact identifier
application applno (ANDA): 075168
application number: ANDA075168

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN605ca130-88aa-27d5-330c-6d9c95987f1f6
849574naproxen sodium 220 MG Oral TabletSCD605ca130-88aa-27d5-330c-6d9c95987f1f6
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY605ca130-88aa-27d5-330c-6d9c95987f1f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-059-5243598005952225 TABLET, COATED in 1 BOTTLE (43598-059-52) 2021-08-050000-00-00NoNoCurrent