Naproxen Sodium

Product NDC
71205-631
11-digit product format
712050631
Labeler code
71205
Product ID
71205-631_0c969467-9318-4dd2-945e-95ec8092a0fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA212199
Marketing category
ANDA
Marketing start
2019-10-30
Substance
NAPROXEN SODIUM
Active strength
550 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212199-001NAPROXEN SODIUMNAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-30
A212199-002NAPROXEN SODIUMNAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A212199-001AB
A212199-002AB

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 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-30782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212199-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212199-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212199-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212199-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212199-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212199-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212199-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212199-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212199-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212199-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212199-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212199-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212199-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212199-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212199-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212199-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212199-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212199-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212199-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212199-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212199-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212199-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212199-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212199-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212199-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212199-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212199-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212199-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212199-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212199-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212199-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212199-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212199-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212199-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212199-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A212199-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212199-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212199-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212199-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A212199-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM550 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
849431Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a90bfc07-d01e-427c-b2df-41bff7612d2fAvailable 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
71205-631-15Naproxen Sodium15 in 1 BOTTLETABLET152
71205-631-30Naproxen Sodium30 in 1 BOTTLETABLET302
71205-631-60Naproxen Sodium60 in 1 BOTTLETABLET602
71205-631-90Naproxen Sodium90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-631-15EA - Each71205-6318139c2cb-92c2-480e-a55f-1a1c672b2a6312022-03-09
71205-631-30EA - Each71205-6318cde1e4b-242e-4ab5-aca8-d4e109aa6ab912022-12-07
71205-631-60EA - Each71205-6310d1ccabf-924c-4eee-9d1a-0471ad90447e12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-631NAPROXEN SODIUM TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 4 package rows20220715_a90bfc07-d01e-427c-b2df-41bff7612d2f.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen SodiumNAPROXEN SODIUMScieGen Pharmaceuticals, Inc.79f48c92-783d-40f2-9865-89958a9f9de62026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212199
application number: ANDA212199
Naproxen SodiumNAPROXEN SODIUMST. MARY'S MEDICAL PARK PHARMACY181c2d5b-2c61-bf20-e063-6294a90a3f7f2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212199
application number: ANDA212199
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepack2794b60d-d09b-4115-9ff2-07ff15524e782026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212199
application number: ANDA212199
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepackbee7b482-8ba5-411d-90ee-de00df50d2b72026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212199
application number: ANDA212199
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepacke9eb8c40-85d9-4c8e-9523-a21d3591260f2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212199
application number: ANDA212199
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepackf6f4a670-235e-4235-84a8-a74dc8ca55862026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212199
application number: ANDA212199
Naproxen SodiumNAPROXEN SODIUMAdvanced Rx of Tennessee, LLC369911ea-9069-9c45-e063-6394a90a5ce62026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212199
application number: ANDA212199
Naproxen SodiumNAPROXEN SODIUMAdvanced Rx of Tennessee, LLC4a05ca8c-1b03-fa86-e063-6394a90a41192026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212199
application number: ANDA212199
Naproxen SodiumNAPROXEN SODIUMPD-Rx Pharmaceuticals, Inc.145cdcc0-9bd5-4a0e-81fc-11a24d1819802026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212199
application number: ANDA212199
Naproxen SodiumNAPROXEN SODIUMPreferred Pharmaceuticals, Inc.6ae413ba-5a48-423f-8b8d-7a42661cf8362025-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212199
application number: ANDA212199
Naproxen SodiumNAPROXEN SODIUMDirect Rxd95279d9-6e2a-0bd6-e053-2a95a90a447d2025-01-21Exact identifier
application applno (ANDA): 212199
application number: ANDA212199
Naproxen SodiumNAPROXEN SODIUMNuCare Pharmaceuticals,Inc.b8e417d2-3fc8-9a5e-e053-2a95a90a41552025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212199
application number: ANDA212199
Naproxen SodiumNAPROXEN SODIUMAsclemed USA, Inc.b0571e62-9330-438d-a2ba-873477f52dc42023-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212199
application number: ANDA212199
Naproxen SodiumNAPROXEN SODIUMProficient Rx LPa90bfc07-d01e-427c-b2df-41bff7612d2f2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212199
application number: ANDA212199
ndc (product): 71205-631

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSNa90bfc07-d01e-427c-b2df-41bff7612d2f2
849431naproxen sodium 550 MG Oral TabletSCDa90bfc07-d01e-427c-b2df-41bff7612d2f2
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSYa90bfc07-d01e-427c-b2df-41bff7612d2f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-631-157120506311515 TABLET in 1 BOTTLE (71205-631-15) 15 tablet2022-01-200000-00-00NoNoCurrent
71205-631-307120506313030 TABLET in 1 BOTTLE (71205-631-30) 30 tablet2022-01-200000-00-00NoNoCurrent
71205-631-607120506316060 TABLET in 1 BOTTLE (71205-631-60) 60 tablet2022-01-200000-00-00NoNoCurrent
71205-631-907120506319090 TABLET in 1 BOTTLE (71205-631-90) 90 tablet2022-01-200000-00-00NoNoCurrent