Naproxen Sodium

Product NDC
70518-2863
11-digit product format
705182863
Labeler code
70518
Product ID
70518-2863_dfe98d6e-f5d1-161b-e053-2995a90a1257
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212199
Marketing category
ANDA
Marketing start
2020-08-27
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-2863DDiscontinued by firm2026-08-07
excluded packagepackage70518-286370518-2863-0DDiscontinued by firm2026-08-07
excluded packagepackage70518-286370518-2863-1DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 13 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-2863-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-2863-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2863-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2863-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2863-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2863-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2863-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2863-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2863-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2863-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2863-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2863-1367a005e9d99…383a685ebd0f…

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…

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2863NAPROXEN SODIUM TABLET [REMEDYREPACK INC.]9Legacy NDC20240921_3882db3d-acb9-4eb8-896f-55697a2a955c.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2863-07051828630030 TABLET in 1 BOTTLE, PLASTIC (70518-2863-0) 30 tablet2020-08-270000-00-00NoNoCurrent
70518-2863-17051828630130 TABLET in 1 BOTTLE, PLASTIC (70518-2863-1) 30 tablet2022-05-240000-00-00NoNoCurrent