Naproxen

Product NDC
35356-684
11-digit product format
353560684
Labeler code
35356
Product ID
35356-684_7354d28d-dea5-4237-a533-f05ef5f81092
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naproxen
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA074201
Marketing category
ANDA
Marketing start
1993-12-22
Marketing end
0000-00-00
Substance
NAPROXEN
Active strength
500 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct35356-684DDiscontinued by firm2026-08-11
excluded packagepackage35356-68435356-684-20DDiscontinued by firm2026-08-11
excluded packagepackage35356-68435356-684-30DDiscontinued by firm2026-08-11
excluded packagepackage35356-68435356-684-60DDiscontinued by firm2026-08-11
excluded packagepackage35356-68435356-684-90DDiscontinued by firm2026-08-11

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 · 60 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 packagepackage35356-684-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35356-684-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35356-684-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35356-684-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-684-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-684-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-684-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-684-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-684-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-684-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-684-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-684-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-684-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-684-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-684-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-684-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-684-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-684-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-684-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-684-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-684-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-684-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-684-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-684-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-684-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-684-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-684-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-684-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-684-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-684-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-684-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-684-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-684-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-684-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-684-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-684-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-684-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-684-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-684-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-684-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-684-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-684-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-684-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-684-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-684-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-684-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-684-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-684-30557ba5c1ecfa…9c80585c8c6e…

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
A074201-001NAPROXENNAPROXEN250MGTABLET / ORALAB1993-12-21
A074201-002NAPROXENNAPROXEN375MGTABLET / ORALAB1993-12-21
A074201-003NAPROXENNAPROXEN500MGTABLET / ORALAB1993-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074201-001AB
A074201-002AB
A074201-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074201-001NAPROXEN250MGTABLET / ORALAB1993-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074201-002NAPROXEN375MGTABLET / ORALAB1993-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074201-003NAPROXEN500MGTABLET / ORALAB1993-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074201-001NAPROXEN250MGTABLET / ORALAB1993-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074201-002NAPROXEN375MGTABLET / ORALAB1993-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074201-003NAPROXEN500MGTABLET / ORALAB1993-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074201-001NAPROXEN250MGTABLET / ORALAB1993-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074201-002NAPROXEN375MGTABLET / ORALAB1993-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074201-003NAPROXEN500MGTABLET / ORALAB1993-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074201-001NAPROXEN250MGTABLET / ORALAB1993-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074201-002NAPROXEN375MGTABLET / ORALAB1993-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074201-003NAPROXEN500MGTABLET / ORALAB1993-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074201-001NAPROXEN250MGTABLET / ORALAB1993-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074201-002NAPROXEN375MGTABLET / ORALAB1993-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074201-003NAPROXEN500MGTABLET / ORALAB1993-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074201-001NAPROXEN250MGTABLET / ORALAB1993-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074201-002NAPROXEN375MGTABLET / ORALAB1993-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074201-003NAPROXEN500MGTABLET / ORALAB1993-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074201-001NAPROXEN250MGTABLET / ORALAB1993-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074201-002NAPROXEN375MGTABLET / ORALAB1993-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074201-003NAPROXEN500MGTABLET / ORALAB1993-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074201-001NAPROXEN250MGTABLET / ORALAB1993-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074201-002NAPROXEN375MGTABLET / ORALAB1993-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074201-003NAPROXEN500MGTABLET / ORALAB1993-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074201-001NAPROXEN250MGTABLET / ORALAB1993-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074201-002NAPROXEN375MGTABLET / ORALAB1993-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074201-003NAPROXEN500MGTABLET / ORALAB1993-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074201-001NAPROXEN250MGTABLET / ORALAB1993-12-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A074201-002NAPROXEN375MGTABLET / ORALAB1993-12-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A074201-003NAPROXEN500MGTABLET / ORALAB1993-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074201-001NAPROXEN250MGTABLET / ORALAB1993-12-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074201-002NAPROXEN375MGTABLET / ORALAB1993-12-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074201-003NAPROXEN500MGTABLET / ORALAB1993-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074201-001NAPROXEN250MGTABLET / ORALAB1993-12-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074201-002NAPROXEN375MGTABLET / ORALAB1993-12-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074201-003NAPROXEN500MGTABLET / ORALAB1993-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074201-001NAPROXEN250MGTABLET / ORALAB1993-12-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074201-002NAPROXEN375MGTABLET / ORALAB1993-12-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074201-003NAPROXEN500MGTABLET / ORALAB1993-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074201-001NAPROXEN250MGTABLET / ORALAB1993-12-218072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074201-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074201-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074201-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074201-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074201-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074201-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074201-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074201-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074201-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074201-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074201-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074201-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074201-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074201-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074201-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074201-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074201-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074201-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074201-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074201-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074201-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074201-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074201-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074201-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074201-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074201-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074201-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074201-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074201-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074201-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074201-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074201-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074201-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074201-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074201-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074201-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074201-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074201-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074201-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074201-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-684-20EA - Each35356-6846673d79a-1543-42e1-a594-33819663f08612016-09-02
35356-684-30EA - Each35356-684068441d3-97a4-448d-83b5-e1d567b5153412016-09-02
35356-684-60EA - Each35356-684527388a7-4989-48fc-8ac1-617ad34ae3e512016-09-02
35356-684-90EA - Each35356-684a3137e1f-9b15-44c6-a55b-eccdee28aa2c12016-09-02