Home NDC 62207-761 Naproxen Sodium
Product NDC 62207-761
11-digit product format 622070761
Labeler code 62207
Product ID 62207-761_f4026a0a-c9cd-3850-e053-2995a90a459c
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Granules India Ltd
Application ANDA091353
Marketing category ANDA
Marketing start 2011-09-30
Substance NAPROXEN SODIUM
Active strength 220 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 2026-12-31
Current FDA listing Yes 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 · 10 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 62207-761 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 62207-761 62207-761-21 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 62207-761 62207-761-22 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 62207-761 62207-761-24 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 62207-761 62207-761-28 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 62207-761 62207-761-31 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 62207-761 62207-761-32 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 62207-761 62207-761-33 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 62207-761 62207-761-34 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 62207-761 62207-761-36 UNFINISHED Active or certified unfinished drug listing 2026-08-17
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 4 · 210 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A091353-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20
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 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091353-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2011-09-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091353-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2011-09-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Naproxen Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAPROXEN SODIUM 220 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 849574 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 62207-761-42 Naproxen Sodium 50 in 1 BOTTLE TABLET, FILM COATED 50 9 62207-761-43 Naproxen Sodium 100 in 1 BOTTLE TABLET, FILM COATED 100 9 62207-761-47 Naproxen Sodium 500 in 1 BOTTLE TABLET, FILM COATED 500 9 62207-761-49 Naproxen Sodium 1000 in 1 BOTTLE TABLET, FILM COATED 1000 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62207-761 NAPROXEN SODIUM TABLET NAPROXEN SODIUM TABLET, FILM COATED [GRANULES INDIA LTD] 9 Current NDC, Legacy NDC, 4 package rows 20230207_95ba1722-60ed-4a83-9f26-50c4de8cf180.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 · 14 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 62207-761-21 62207076121 5000 TABLET, FILM COATED in 1 BOX (62207-761-21) 12-MAR-14 Current 62207-761-22 62207076122 25000 TABLET, FILM COATED in 1 BOX (62207-761-22) 12-MAR-14 Current 62207-761-24 62207076124 48000 TABLET, FILM COATED in 1 BOX (62207-761-24) 12-MAR-14 Current 62207-761-28 62207076128 50000 TABLET, FILM COATED in 1 BOX (62207-761-28) 12-MAR-14 Current 62207-761-31 62207076131 5000 TABLET, FILM COATED in 1 POUCH (62207-761-31) 12-MAR-14 Current 62207-761-32 62207076132 10000 TABLET, FILM COATED in 1 POUCH (62207-761-32) 12-MAR-14 Current 62207-761-33 62207076133 25000 TABLET, FILM COATED in 1 POUCH (62207-761-33) 12-MAR-14 Current 62207-761-34 62207076134 15000 TABLET, FILM COATED in 1 POUCH (62207-761-34) 12-MAR-14 Current 62207-761-36 62207076136 50000 TABLET, FILM COATED in 1 POUCH (62207-761-36) 12-MAR-14 Current 62207-761-42 62207076142 50 TABLET, FILM COATED in 1 BOTTLE (62207-761-42) 2011-09-30 0000-00-00 No No Current 62207-761-43 62207076143 100 TABLET, FILM COATED in 1 BOTTLE (62207-761-43) 2011-09-30 0000-00-00 No No Current 62207-761-47 62207076147 500 TABLET, FILM COATED in 1 BOTTLE (62207-761-47) 2011-09-30 0000-00-00 No No Current 62207-761-49 62207076149 1000 TABLET, FILM COATED in 1 BOTTLE (62207-761-49) 2011-09-30 0000-00-00 No No Current