Home NDC 65862-928-36 Sumatriptan and Naproxen Sodium
Product NDC 65862-928
Requested package NDC 65862-928-36
11-digit product format 658620928
Labeler code 65862
Product ID 65862-928_b0441826-19e2-4113-89b7-727a2b882a09
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sumatriptan and Naproxen Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA207457
Marketing category ANDA
Marketing start 2018-02-15
Substance SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM
Active strength 85; 500 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 43 .
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 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207457-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207457-001 SUMATRIPTAN AND NAPROXEN SODIUM 500MG;EQ 85MG BASE TABLET / ORAL AB 2018-02-15 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 65862-928-36 Sumatriptan and Naproxen Sodium 9 in 1 BOTTLE TABLET, FILM COATED 9 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-928 SUMATRIPTAN AND NAPROXEN SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 9 Current NDC, Legacy NDC, 1 package rows 20241213_f5203c66-0a40-4263-a237-b71e930e4697.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 · 1 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 65862-928-36 65862092836 9 TABLET, FILM COATED in 1 BOTTLE (65862-928-36) 2018-02-15 0000-00-00 No No Current