Naproxen Sodium

Product NDC
59726-751
11-digit product format
597260751
Labeler code
59726
Product ID
59726-751_2a68267b-0fa0-4b09-b8a8-15f11aaa71f9
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
P & L Development, LLC
Application
ANDA202807
Marketing category
ANDA
Marketing start
2020-12-04
Marketing end
2026-12-31
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
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
A202807-001NAPROXEN SODIUMNAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-043f01610625f2…
2019-09-15 20:21 UTC2019-09A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202807-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2019-01-04cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium

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
1112231Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3bd60171-c073-441a-8d59-c85efee69e07Available 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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59726-751-20Naproxen Sodium1 in 1 BOXCAPSULE14
59726-751-20Naproxen Sodium20 in 1 BOTTLE, PLASTICCAPSULE204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-751NAPROXEN SODIUM CAPSULE [P & L DEVELOPMENT, LLC]3Current NDC, Legacy NDC, 2 package rows20241107_3bd60171-c073-441a-8d59-c85efee69e07.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen SodiumNAPROXEN SODIUMP & L Development, LLC3bd60171-c073-441a-8d59-c85efee69e072025-11-17WarningsExact identifier
application applno (ANDA): 202807
application number: ANDA202807
ndc (product): 59726-751
Naproxen SodiumNAPROXEN SODIUMWalgreensa380cace-43dc-4b9c-84d3-0b38241d9d2e2022-03-30WarningsExact identifier
application applno (ANDA): 202807
application number: ANDA202807

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1112231naproxen sodium 220 MG Oral CapsulePSN3bd60171-c073-441a-8d59-c85efee69e074
1112231naproxen sodium 220 MG Oral CapsuleSCD3bd60171-c073-441a-8d59-c85efee69e074
1112231naproxen sodium 220 MG (as naproxen 200 MG) Oral CapsuleSY3bd60171-c073-441a-8d59-c85efee69e074

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59726-751-20597260751201 BOTTLE, PLASTIC in 1 BOX (59726-751-20) / 20 CAPSULE in 1 BOTTLE, PLASTIC2020-12-042026-12-31NoNoCurrent