Naproxen Sodium

Product NDC
11673-764
Requested package NDC
11673-764-05
11-digit product format
116730764
Labeler code
11673
Product ID
11673-764_46532fbb-e0e4-8e66-e063-6394a90a2a2a
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
TARGET CORPORATION
Application
ANDA091353
Marketing category
ANDA
Marketing start
2024-03-01
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
A091353-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2011-09-20

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rapidol NaproxenNAPROXEN SODIUMPharmadel LLCc94c4b6e-a48b-cee5-e053-2995a90a49ac2026-03-20WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
Naproxen SodiumNAPROXEN SODIUMGranules USA, Inc.8cb8030c-b281-315c-e053-2a95a90a36f02025-12-22WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
NaproxenNAPROXENSafeway, Incf2a273f8-d623-dc2f-e053-2995a90a0c022025-12-19WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
Naproxen SodiumNAPROXEN SODIUMSafeway, Incf2a297c2-3898-5e47-e053-2995a90ab3cc2025-12-19WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
Naproxen SodiumNAPROXEN SODIUMTARGET CORPORATIONfdb87abd-3176-dd62-e053-6394a90a6fcc2025-12-19WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
ndc (package): 11673-764-05
ndc (product): 11673-764
ndc11 (package): 11673076405
Naproxen SodiumNAPROXEN SODIUMCVS1042b202-e8ee-1839-e063-6294a90ac90b2025-12-19WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
Naproxen SodiumNAPROXEN SODIUMCVS10429d07-de96-5542-e063-6294a90a73712025-12-19WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
Dr Simi All Day Pain ReliefNAPROXEN SODIUMFarmacias De Similares TX LLC3c6d4bb5-eb6f-944b-e063-6294a90ae8de2025-08-15WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
Naproxen SodiumNAPROXEN SODIUMBi-Mart6d5cecc9-5095-477b-bfc7-45b6e7e689f02025-03-01WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
NAPROXEN SODIUMNAPROXEN SODIUMSPIRIT PHARMACEUTICALS,LLCa690dc39-95f2-4853-a291-05d7dc9a15512024-12-30WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
Pain ReliefNAPROXEN SODIUMGobrands, Incae4bfa8c-ae41-4fcd-b584-872cc4d376832024-12-20WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
PROXEN NP 660NAPROXEN SODIUMOPMX LLC09990b2f-202e-b4df-e063-6394a90a055b2023-12-27WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
Naproxen SodiumNAPROXEN SODIUMGranules India Ltd95ba1722-60ed-4a83-9f26-50c4de8cf1802023-02-06WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353
All Day Pain ReliefNAPROXEN SODIUM TABLETS, 220 MGHealthLife of USA LLC7b0cb91e-5465-40ef-9f82-919f7d984f172017-06-01WarningsExact identifier
application applno (ANDA): 091353
application number: ANDA091353

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium
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
fdb87abd-3176-dd62-e053-6394a90a6fccAvailable 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
11673-764-05Naproxen Sodium50 in 1 BOTTLETABLET505
11673-764-09Naproxen Sodium90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-764NAPROXEN SODIUM TABLET [TARGET CORPORATION]3Current NDC, 2 package rows20241120_fdb87abd-3176-dd62-e053-6394a90a6fcc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNfdb87abd-3176-dd62-e053-6394a90a6fcc5
849574naproxen sodium 220 MG Oral TabletSCDfdb87abd-3176-dd62-e053-6394a90a6fcc5
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYfdb87abd-3176-dd62-e053-6394a90a6fcc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11673-764-051167307640550 TABLET in 1 BOTTLE (11673-764-05) 50 tablet2024-03-01NoNoCurrent