Naproxen Sodium

Product NDC
71335-9663
Requested package NDC
71335-9663-0
11-digit product format
713359663
Labeler code
71335
Product ID
71335-9663_991ca4e2-175c-457d-b2e6-62b1cb17e7f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-3084e616aacf4f…
2026-09-14 22:38:342026-08A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-3084e616aacf4f…
2026-08-18 06:07:402026-07A212199-001NAPROXEN SODIUMEQ 250MG BASETABLET / ORALAB2019-10-30caaa826d4ba7…
2026-08-18 06:07:402026-07A212199-002NAPROXEN SODIUMEQ 500MG BASETABLET / ORALAB2019-10-30caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A212199-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A212199-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A212199-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212199-002AB1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Naproxen Sodium
Listing expiration
2027-12-31

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
f6f4a670-235e-4235-84a8-a74dc8ca5586Available 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
71335-9663-0Naproxen Sodium6 in 1 BOTTLETABLET6102
71335-9663-1Naproxen Sodium20 in 1 BOTTLETABLET20102
71335-9663-2Naproxen Sodium100 in 1 BOTTLETABLET100102
71335-9663-3Naproxen Sodium30 in 1 BOTTLETABLET30102
71335-9663-4Naproxen Sodium120 in 1 BOTTLETABLET120102
71335-9663-5Naproxen Sodium60 in 1 BOTTLETABLET60102
71335-9663-6Naproxen Sodium90 in 1 BOTTLETABLET90102
71335-9663-7Naproxen Sodium42 in 1 BOTTLETABLET42102
71335-9663-8Naproxen Sodium14 in 1 BOTTLETABLET14102
71335-9663-9Naproxen Sodium56 in 1 BOTTLETABLET56102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9663-3EA - Each71335-9663e5ddb3d7-f747-4ed3-afe1-0c4df9d322a512025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9663NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [BRYANT RANCH PREPACK]101Current NDC, 10 package rows20231019_f6f4a670-235e-4235-84a8-a74dc8ca5586.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 SODIUMBryant Ranch Prepackf6f4a670-235e-4235-84a8-a74dc8ca55862026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212199
application number: ANDA212199
ndc (package): 71335-9663-0
ndc (product): 71335-9663
ndc11 (package): 71335966300
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepack2794b60d-d09b-4115-9ff2-07ff15524e782026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212199
application number: ANDA212199
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepackbee7b482-8ba5-411d-90ee-de00df50d2b72026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212199
application number: ANDA212199
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepacke9eb8c40-85d9-4c8e-9523-a21d3591260f2026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212199
application number: ANDA212199
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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849431naproxen sodium 550 MG Oral TabletPSNf6f4a670-235e-4235-84a8-a74dc8ca5586102
849431naproxen sodium 550 MG Oral TabletSCDf6f4a670-235e-4235-84a8-a74dc8ca5586102
849431naproxen sodium 550 MG (as naproxen 500 MG) Oral TabletSYf6f4a670-235e-4235-84a8-a74dc8ca5586102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9663-0713359663006 TABLET in 1 BOTTLE (71335-9663-0) 6 tablet2023-04-20NoNoCurrent