Naproxen

Product NDC
68382-013
11-digit product format
683820013
Labeler code
68382
Product ID
68382-013_29a5000d-5ff1-4482-ad9d-3d36570b1e67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA078620
Marketing category
ANDA
Marketing start
2008-09-19
Marketing end
0000-00-00
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
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68382-013DDiscontinued by firm2026-10-05
excluded packagepackage68382-01368382-013-01DDiscontinued by firm2026-10-05
excluded packagepackage68382-01368382-013-05DDiscontinued by firm2026-10-05
excluded packagepackage68382-01368382-013-10DDiscontinued by firm2026-10-05

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 · 8 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 packagepackage68382-013-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-013-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-013-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-013-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-013-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-013-01f5e01cc5f278…a2eaf40c39c3…

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

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
A078620-001NAPROXENNAPROXEN250MGTABLET / ORALAB2007-06-07
A078620-002NAPROXENNAPROXEN375MGTABLET / ORALAB2007-06-07
A078620-003NAPROXENNAPROXEN500MGTABLET / ORALAB2007-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078620-001AB
A078620-002AB
A078620-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078620-001NAPROXEN250MGTABLET / ORALAB2007-06-0784e616aacf4f…
2026-09-14 22:38:342026-08A078620-002NAPROXEN375MGTABLET / ORALAB2007-06-0784e616aacf4f…
2026-09-14 22:38:342026-08A078620-003NAPROXEN500MGTABLET / ORALAB2007-06-0784e616aacf4f…
2026-08-18 06:07:402026-07A078620-001NAPROXEN250MGTABLET / ORALAB2007-06-07caaa826d4ba7…
2026-08-18 06:07:402026-07A078620-002NAPROXEN375MGTABLET / ORALAB2007-06-07caaa826d4ba7…
2026-08-18 06:07:402026-07A078620-003NAPROXEN500MGTABLET / ORALAB2007-06-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078620-001NAPROXEN250MGTABLET / ORALAB2007-06-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078620-002NAPROXEN375MGTABLET / ORALAB2007-06-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078620-003NAPROXEN500MGTABLET / ORALAB2007-06-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078620-001NAPROXEN250MGTABLET / ORALAB2007-06-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078620-002NAPROXEN375MGTABLET / ORALAB2007-06-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078620-003NAPROXEN500MGTABLET / ORALAB2007-06-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078620-001NAPROXEN250MGTABLET / ORALAB2007-06-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078620-002NAPROXEN375MGTABLET / ORALAB2007-06-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078620-003NAPROXEN500MGTABLET / ORALAB2007-06-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078620-001NAPROXEN250MGTABLET / ORALAB2007-06-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078620-002NAPROXEN375MGTABLET / ORALAB2007-06-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078620-003NAPROXEN500MGTABLET / ORALAB2007-06-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078620-001NAPROXEN250MGTABLET / ORALAB2007-06-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078620-002NAPROXEN375MGTABLET / ORALAB2007-06-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078620-003NAPROXEN500MGTABLET / ORALAB2007-06-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078620-001NAPROXEN250MGTABLET / ORALAB2007-06-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078620-002NAPROXEN375MGTABLET / ORALAB2007-06-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078620-003NAPROXEN500MGTABLET / ORALAB2007-06-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078620-001NAPROXEN250MGTABLET / ORALAB2007-06-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078620-002NAPROXEN375MGTABLET / ORALAB2007-06-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078620-003NAPROXEN500MGTABLET / ORALAB2007-06-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078620-001NAPROXEN250MGTABLET / ORALAB2007-06-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078620-002NAPROXEN375MGTABLET / ORALAB2007-06-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078620-003NAPROXEN500MGTABLET / ORALAB2007-06-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078620-001NAPROXEN250MGTABLET / ORALAB2007-06-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078620-002NAPROXEN375MGTABLET / ORALAB2007-06-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078620-003NAPROXEN500MGTABLET / ORALAB2007-06-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078620-001NAPROXEN250MGTABLET / ORALAB2007-06-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A078620-002NAPROXEN375MGTABLET / ORALAB2007-06-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A078620-003NAPROXEN500MGTABLET / ORALAB2007-06-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078620-001NAPROXEN250MGTABLET / ORALAB2007-06-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078620-002NAPROXEN375MGTABLET / ORALAB2007-06-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078620-003NAPROXEN500MGTABLET / ORALAB2007-06-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078620-001NAPROXEN250MGTABLET / ORALAB2007-06-07301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078620-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078620-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078620-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A078620-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078620-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078620-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078620-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078620-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078620-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078620-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078620-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078620-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078620-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078620-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078620-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078620-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078620-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078620-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078620-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078620-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078620-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078620-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078620-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078620-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078620-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078620-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078620-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078620-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078620-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078620-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078620-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078620-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078620-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078620-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078620-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078620-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078620-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078620-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078620-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078620-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN (NAPROXEN) TABLET [ZYDUS PHARMACEUTICALS USA INC.]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN (NAPROXEN) TABLET [ZYDUS PHARMACEUTICALS USA INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTNAPROXEN (NAPROXEN) TABLET [ZYDUS PHARMACEUTICALS USA INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNAPROXEN (NAPROXEN) TABLET [ZYDUS PHARMACEUTICALS USA INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN (NAPROXEN) TABLET [ZYDUS PHARMACEUTICALS USA INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN (NAPROXEN) TABLET [ZYDUS PHARMACEUTICALS USA INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-013-0168382001301100 TABLET in 1 BOTTLE (68382-013-01) 100 tablet2008-09-190000-00-00NoNoCurrent
68382-013-0568382001305500 TABLET in 1 BOTTLE (68382-013-05) 500 tablet2008-09-190000-00-00NoNoCurrent
68382-013-10683820013101000 TABLET in 1 BOTTLE (68382-013-10) 1000 tablet2008-09-190000-00-00NoNoCurrent