Naproxen

Product NDC
51655-743
Requested package NDC
51655-743-52
11-digit product format
516550743
Labeler code
51655
Product ID
51655-743_4ba9ffdd-00a3-39ed-e063-6394a90ab827
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA212517
Marketing category
ANDA
Marketing start
2021-06-29
Substance
NAPROXEN
Active strength
500 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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212517-001NAPROXENNAPROXEN250MGTABLET / ORALAB2020-02-21
A212517-002NAPROXENNAPROXEN375MGTABLET / ORALAB2020-02-21
A212517-003NAPROXENNAPROXEN500MGTABLET / ORALAB2020-02-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A212517-001AB
A212517-002AB
A212517-003AB

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 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212517-002NAPROXEN375MGTABLET / ORALAB2020-02-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212517-003NAPROXEN500MGTABLET / ORALAB2020-02-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212517-001NAPROXEN250MGTABLET / ORALAB2020-02-218072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212517-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212517-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212517-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212517-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212517-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212517-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212517-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212517-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212517-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212517-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212517-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212517-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212517-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212517-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212517-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212517-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212517-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212517-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212517-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212517-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212517-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212517-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212517-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212517-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212517-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212517-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212517-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212517-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212517-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212517-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212517-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212517-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212517-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212517-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212517-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212517-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212517-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212517-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212517-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212517-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
57Y76R9ATQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198014Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c986ba9a-6f48-8347-e053-2a95a90aa1c1Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-743-20Naproxen20 in 1 BOTTLE, PLASTICTABLET205
51655-743-25Naproxen60 in 1 BOTTLE, PLASTICTABLET605
51655-743-26Naproxen90 in 1 BOTTLE, PLASTICTABLET905
51655-743-52Naproxen30 in 1 BOTTLE, PLASTICTABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-743NAPROXEN TABLET [NORTHWIND PHARMACEUTICALS]2Current NDC, Legacy NDC, 4 package rows20230419_c986ba9a-6f48-8347-e053-2a95a90aa1c1.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 2 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENPreferred Pharmaceuticals Inc.49a00870-f580-4eb9-a95d-48fa956f147f2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENPreferred Pharmaceuticals, Inc.9f026fd5-f996-4383-b528-841d38d3dab52026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENHAWAII REPACK, INC.888efc91-b4de-4691-b84c-fb871e7a6dfe2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENSt. Mary's Medical Park Pharmacye3a3e5d2-2d1e-74d3-e053-2995a90a82bf2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENREMEDYREPACK INC.ccd95dfc-9236-4707-a715-6a12c91519ff2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENST. MARY'S MEDICAL PARK PHARMACYe3a4ab4a-b109-eb5e-e053-2a95a90afddd2026-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENBryant Ranch Prepack2e72de28-e62b-44e0-b17d-500d13e0bcc62026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENBryant Ranch Prepackbbc61c0a-491a-4f50-a7bf-2ca94c7715682026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENSportpharm LLC1c5b2bc1-26bb-4f88-bded-399263c823312026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENBryant Ranch Prepackf18181f4-6b14-48a8-a149-e45b3360a2502026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENBryant Ranch Prepack97d6c4ef-13b1-4b0b-a15a-f0590019940d2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENBryant Ranch Prepack852fed15-e78b-47a8-aeb4-623dfe1edad92026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENREMEDYREPACK INC.6bb65680-76ea-46e5-ae70-f3091e3603682026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENRadha Pharmaceuticals, Inc.1a2b9a82-5b79-45ee-94ed-7a6f8c8b51702026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENScieGen Pharmaceuticals, Inc.81e22c1f-f94d-46e9-8b7d-72dc2518319e2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENNuCare Pharmaceuticals,Inc.c136cf75-4ad4-8634-e053-2a95a90a53a42026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.fa2fe6fd-c476-dd29-e053-6294a90a9e9e2026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENNorthwind Health Company, LLCdb478961-d984-7c8e-e053-2995a90a8a122026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
NaproxenNAPROXENNorthwind Health Company, LLCc986ba9a-6f48-8347-e053-2a95a90aa1c12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
ndc (package): 51655-743-52
ndc (product): 51655-743
ndc11 (package): 51655074352
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.24d44eb6-921e-4150-a6b2-81f42ced32ab2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198014naproxen 500 MG Oral TabletPSNc986ba9a-6f48-8347-e053-2a95a90aa1c15
198014naproxen 500 MG Oral TabletSCDc986ba9a-6f48-8347-e053-2a95a90aa1c15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-743-525165507435230 TABLET in 1 BOTTLE, PLASTIC (51655-743-52) 30 tablet2021-06-290000-00-00NoNoCurrent