Naproxen Sodium

Product NDC
0363-7510
11-digit product format
003637510
Labeler code
0363
Product ID
0363-7510_e5a5fe51-e1a2-4103-b1f5-2a2d33e79307
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
ANDA202807
Marketing category
ANDA
Marketing start
2020-01-31
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
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
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
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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a380cace-43dc-4b9c-84d3-0b38241d9d2eAvailable 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
0363-7510-20Naproxen Sodium20 in 1 BOTTLE, PLASTICTABLET202
0363-7510-20Naproxen Sodium1 in 1 BOXTABLET12
0363-7510-40Naproxen Sodium40 in 1 BOTTLE, PLASTICTABLET402
0363-7510-40Naproxen Sodium1 in 1 BOXTABLET12
0363-7510-50Naproxen Sodium1 in 1 BOXTABLET12
0363-7510-50Naproxen Sodium50 in 1 BOTTLE, PLASTICTABLET502
0363-7510-80Naproxen Sodium80 in 1 BOTTLE, PLASTICTABLET802
0363-7510-80Naproxen Sodium1 in 1 BOXTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-7510NAPROXEN SODIUM TABLET [WALGREENS]2Current NDC, Legacy NDC, 8 package rows20220331_a380cace-43dc-4b9c-84d3-0b38241d9d2e.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
Naproxen SodiumNAPROXEN SODIUMWalgreensa380cace-43dc-4b9c-84d3-0b38241d9d2e2022-03-30WarningsExact identifier
application applno (ANDA): 202807
application number: ANDA202807
ndc (product): 0363-7510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-7510-20003637510201 BOTTLE, PLASTIC in 1 BOX (0363-7510-20) / 20 TABLET in 1 BOTTLE, PLASTIC2020-01-310000-00-00NoNoCurrent
0363-7510-40003637510401 BOTTLE, PLASTIC in 1 BOX (0363-7510-40) / 40 TABLET in 1 BOTTLE, PLASTIC2020-01-310000-00-00NoNoCurrent
0363-7510-50003637510501 BOTTLE, PLASTIC in 1 BOX (0363-7510-50) / 50 TABLET in 1 BOTTLE, PLASTIC2020-01-310000-00-00NoNoCurrent
0363-7510-80003637510801 BOTTLE, PLASTIC in 1 BOX (0363-7510-80) / 80 TABLET in 1 BOTTLE, PLASTIC2020-01-310000-00-00NoNoCurrent