Home NDC 68210-0400 NAPROXEN SODIUM
Product NDC 68210-0400
11-digit product format 682100400
Labeler code 68210
Product ID 68210-0400_d2048522-dc5e-715c-e053-2995a90abba1
Type HUMAN OTC DRUG
Nonproprietary name NAPROXEN SODIUM
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler SPIRIT PHARMACEUTICALS,LLC
Application ANDA090545
Marketing category ANDA
Marketing start 2017-11-22
Marketing end 0000-00-00
Substance NAPROXEN SODIUM
Active strength 220 mg/1
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A090545-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090545-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2011-03-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090545-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2011-03-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090545-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-03-16 cb3db0bc1861…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NAPROXEN SODIUM ACTIVE INGREDIENT 9TN87S3A3C NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] 2 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] 2 FD&C BLUE No. 2 INACTIVE INGREDIENT L06K8R7DQK NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] 2
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 2 · 22 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68210-0400-0 68210040000 1 BOTTLE in 1 CARTON (68210-0400-0) > 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE 1 bottle 2017-12-22 0000-00-00 No No Current 68210-0400-1 68210040001 1 BOTTLE in 1 CARTON (68210-0400-1) > 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE 1 bottle 2017-11-22 0000-00-00 No No Current