Home NDC 47335-410 Sumatriptan and Naproxen Sodium
Product NDC 47335-410
11-digit product format 473350410
Labeler code 47335
Product ID 47335-410_c67d3234-28c7-40a9-a472-87747bb4242a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sumatriptan and Naproxen Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA202803
Marketing category ANDA
Marketing start 2018-07-20
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202803-001 AB
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 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202803-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-07-20 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sumatriptan and Naproxen Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUMATRIPTAN SUCCINATE 85 mg/1 NAPROXEN SODIUM 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J8BDZ68989 Internal UNII lookup 9TN87S3A3C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849450 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 47335-410-22 Sumatriptan and Naproxen Sodium 9 in 1 BOTTLE TABLET, FILM COATED 9 15 47335-410-83 Sumatriptan and Naproxen Sodium 30 in 1 BOTTLE TABLET, FILM COATED 30 15 47335-410-88 Sumatriptan and Naproxen Sodium 100 in 1 BOTTLE TABLET, FILM COATED 100 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47335-410 SUMATRIPTAN AND NAPROXEN SODIUM TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 14 Current NDC, Legacy NDC, 3 package rows 20241222_96ed12a3-fa76-4afd-bee8-1ab19eb607f3.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 47335-410-22 47335041022 9 TABLET, FILM COATED in 1 BOTTLE (47335-410-22) 2018-07-20 0000-00-00 No No Current 47335-410-83 47335041083 30 TABLET, FILM COATED in 1 BOTTLE (47335-410-83) 2018-07-20 0000-00-00 No No Current 47335-410-88 47335041088 100 TABLET, FILM COATED in 1 BOTTLE (47335-410-88) 2018-07-20 0000-00-00 No No Current