Treximet

Product NDC
42847-850
11-digit product format
428470850
Labeler code
42847
Product ID
42847-850_ed866a98-f50a-48af-8ad7-9b139a8a6bc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate and Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Currax Pharmaceuticals LLC
Application
NDA021926
Marketing category
NDA
Marketing start
2008-04-25
Substance
NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Active strength
500; 85 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [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 42.

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
N021926-001TREXIMETNAPROXEN SODIUM; SUMATRIPTAN SUCCINATE500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15
N021926-002TREXIMETNAPROXEN SODIUM; SUMATRIPTAN SUCCINATE60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021926-001AB

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021926-00173321832025-10-02U-867Drug product
N021926-0017332183*PED2026-04-02Pediatric extension
N021926-00273321832025-10-02U-1719Drug product2015-07-27
N021926-0027332183*PED2026-04-02Pediatric extension

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15caaa826d4ba7…
2026-08-18 06:07:402026-07N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15d06236e962d9…
2024-10-29 15:01 UTC2024-10N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021926-001TREXIMET500MG;EQ 85MG BASETABLET / ORALABRLD, RS2008-04-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021926-002TREXIMET60MG;EQ 10MG BASETABLET / ORALRLD2015-05-14bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N021926-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021926-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021926-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021926-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021926-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021926-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021926-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021926-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021926-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021926-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021926-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021926-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021926-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021926-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021926-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021926-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021926-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021926-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021926-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021926-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021926-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021926-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021926-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021926-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021926-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021926-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021926-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021926-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021926-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021926-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021926-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021926-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021926-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021926-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021926-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021926-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021926-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021926-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021926-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021926-001AB1e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N021926-00173321832025-10-02U-867Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N021926-0017332183*PED2026-04-02Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N021926-00273321832025-10-02U-1719Drug product2015-07-27caaa826d4ba7…
2026-08-18 06:07:402026-07N021926-0027332183*PED2026-04-02Pediatric extensioncaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021926-00173321832025-10-02U-867Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021926-0017332183*PED2026-04-02Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021926-00273321832025-10-02U-1719Drug product2015-07-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021926-0027332183*PED2026-04-02Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021926-00173321832025-10-02U-867Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021926-0017332183*PED2026-04-02Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021926-00273321832025-10-02U-1719Drug product2015-07-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021926-0027332183*PED2026-04-02Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N021926-00173321832025-10-02U-867Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021926-0017332183*PED2026-04-02Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021926-00273321832025-10-02U-1719Drug product2015-07-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021926-0027332183*PED2026-04-02Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021926-00173321832025-10-02U-867Drug productfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021926-0017332183*PED2026-04-02Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021926-00273321832025-10-02U-1719Drug product2015-07-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021926-0027332183*PED2026-04-02Pediatric extensionfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021926-00173321832025-10-02U-867Drug productb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021926-0017332183*PED2026-04-02Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021926-00273321832025-10-02U-1719Drug product2015-07-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021926-0027332183*PED2026-04-02Pediatric extensionb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021926-00173321832025-10-02U-867Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021926-0017332183*PED2026-04-02Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021926-00273321832025-10-02U-1719Drug product2015-07-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021926-0027332183*PED2026-04-02Pediatric extension03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021926-00173321832025-10-02U-867Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021926-0017332183*PED2026-04-02Pediatric extension2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021926-00273321832025-10-02U-1719Drug product2015-07-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021926-0027332183*PED2026-04-02Pediatric extension2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021926-00173321832025-10-02U-867Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021926-0017332183*PED2026-04-02Pediatric extension5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021926-00273321832025-10-02U-1719Drug product2015-07-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021926-0027332183*PED2026-04-02Pediatric extension5bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021926-00173321832025-10-02U-867Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021926-0017332183*PED2026-04-02Pediatric extensiond8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021926-00273321832025-10-02U-1719Drug product2015-07-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021926-0027332183*PED2026-04-02Pediatric extensiond8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Treximet
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN SUCCINATE500 mg/1
NAPROXEN SODIUM85 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J8BDZ68989Internal UNII lookup
9TN87S3A3CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
849450Internal RxNorm lookup
849452Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
42ddf376-8dc0-4236-be2a-0c6ae92ece04Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2Product name420250724
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
2839c963-7eb3-970a-287f-ff1b6d381268Product name220250103
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
1e973b2d-e028-69cd-9258-4613ba80fdc5Product name320210512
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
3eb481d3-8b69-436f-82dd-4a66345568abProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877cProduct name120160303
49615343-b619-4365-8118-8f2ed6046e78Product name120160224
a6319377-430a-43db-82f9-30d1d9d89cf8Product name120151216
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42847-850-09Treximet9 in 1 BOTTLETABLET, FILM COATED98

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42847-850-09EA - Each42847-85085950de1-2bf4-4855-962a-da004b88dbfa12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42847-850TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [CURRAX PHARMACEUTICALS LLC]8Current NDC, Legacy NDC, 1 package rows20241226_42ddf376-8dc0-4236-be2a-0c6ae92ece04.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sumatriptan Succinate and Naproxen SodiumSUMATRIPTAN SUCCINATE AND NAPROXEN SODIUMCurrax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven5762bbe6-bddf-495c-adf8-9096f98a3a9c2024-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021926
application number: NDA021926
TreximetSUMATRIPTAN SUCCINATE AND NAPROXEN SODIUMCurrax Pharmaceuticals LLC42ddf376-8dc0-4236-be2a-0c6ae92ece042024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021926
application number: NDA021926
ndc (product): 42847-850

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849450SUMAtriptan 85 MG / naproxen sodium 500 MG Oral TabletPSN42ddf376-8dc0-4236-be2a-0c6ae92ece048
849452Treximet 85 MG / 500 MG Oral TabletPSN42ddf376-8dc0-4236-be2a-0c6ae92ece048
849452naproxen sodium 500 MG / sumatriptan 85 MG Oral Tablet [Treximet]SBD42ddf376-8dc0-4236-be2a-0c6ae92ece048
849450naproxen sodium 500 MG / sumatriptan 85 MG Oral TabletSCD42ddf376-8dc0-4236-be2a-0c6ae92ece048
849450naproxen sodium 500 MG / sumatriptan (as sumatriptan succinate) 85 MG Oral TabletSY42ddf376-8dc0-4236-be2a-0c6ae92ece048
849452Treximet (naproxen sodium 500 MG / sumatriptan 85 MG (as sumatriptan succinate 119 MG)) Oral TabletSY42ddf376-8dc0-4236-be2a-0c6ae92ece048
849452Treximet 85/500 (sumitriptan / naproxen sodium) Oral TabletSY42ddf376-8dc0-4236-be2a-0c6ae92ece048

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42847-850-09428470850099 TABLET, FILM COATED in 1 BOTTLE (42847-850-09) 2008-04-250000-00-00NoNoCurrent