Naproxen

Product NDC
68788-7946
11-digit product format
687887946
Labeler code
68788
Product ID
68788-7946_2d1cb1b6-3ef0-48e8-81a4-86e23528d55a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA212517
Marketing category
ANDA
Marketing start
2021-06-28
Substance
NAPROXEN
Active strength
375 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 · 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
NAPROXEN375 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
198012Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9f026fd5-f996-4383-b528-841d38d3dab5Available 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
68788-7946-1Naproxen100 in 1 BOTTLETABLET1005
68788-7946-2Naproxen20 in 1 BOTTLETABLET205
68788-7946-3Naproxen30 in 1 BOTTLETABLET305
68788-7946-6Naproxen60 in 1 BOTTLETABLET605
68788-7946-8Naproxen120 in 1 BOTTLETABLET1205
68788-7946-9Naproxen90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7946-1EA - Each68788-79461ef0ac3a-fb89-4092-9a81-54bf531f608b12021-07-15
68788-7946-2EA - Each68788-7946c672bf61-4ea9-409e-aca5-033812ac064f12021-07-15
68788-7946-3EA - Each68788-7946c7c2a7ea-1bca-4a73-8b20-033ce6f4f56712021-07-15
68788-7946-6EA - Each68788-79460e9fd521-aa0c-4b1f-b31a-a58881384f6612021-07-15
68788-7946-8EA - Each68788-794684125472-07a5-4588-9ca4-f852f1299df412021-07-15
68788-7946-9EA - Each68788-7946d1d15610-e3d7-4a00-b041-b369a955954112021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7946NAPROXEN TABLET [PREFERRED PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 6 package rows20240724_9f026fd5-f996-4383-b528-841d38d3dab5.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
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.24d44eb6-921e-4150-a6b2-81f42ced32ab2026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212517
application number: ANDA212517
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
ndc (product): 68788-7946
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198012naproxen 375 MG Oral TabletPSN9f026fd5-f996-4383-b528-841d38d3dab55
198012naproxen 375 MG Oral TabletSCD9f026fd5-f996-4383-b528-841d38d3dab55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7946-168788794601100 TABLET in 1 BOTTLE (68788-7946-1) 100 tablet2021-06-280000-00-00NoNoCurrent
68788-7946-26878879460220 TABLET in 1 BOTTLE (68788-7946-2) 20 tablet2021-06-280000-00-00NoNoCurrent
68788-7946-36878879460330 TABLET in 1 BOTTLE (68788-7946-3) 30 tablet2021-06-280000-00-00NoNoCurrent
68788-7946-66878879460660 TABLET in 1 BOTTLE (68788-7946-6) 60 tablet2021-06-280000-00-00NoNoCurrent
68788-7946-868788794608120 TABLET in 1 BOTTLE (68788-7946-8) 120 tablet2021-06-280000-00-00NoNoCurrent
68788-7946-96878879460990 TABLET in 1 BOTTLE (68788-7946-9) 90 tablet2021-06-280000-00-00NoNoCurrent