Home NDC 64597-301 NUEDEXTA
Product NDC 64597-301
11-digit product format 645970301
Labeler code 64597
Product ID 64597-301_545d121c-01b2-4375-9067-52fc8ad23d74
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dextromethorphan hydrobromide and quinidine sulfate
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Avanir Pharmaceuticals, Inc.
Application NDA021879
Marketing category NDA
Marketing start 2010-12-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
Active strength 20; 10 mg/1; mg/1
Pharmacologic classes Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64597-301-60 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64597-301-13 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64597-301-60 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64597-301-13 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64597-301-60 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64597-301-13 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64597-301-60 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64597-301-13 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64597-301-60 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64597-301-13 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64597-301-60 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64597-301-13 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64597-301-60 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64597-301-13 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64597-301-60 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64597-301-13 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 N021879-001 NUEDEXTA DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021879-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021879-001 7659282 2026-08-13 U-1093
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 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 65 observed states.
Additional Listing Data#
Finished product Yes
Brand name base NUEDEXTA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1 QUINIDINE SULFATE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup J13S2394HE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1040054 Internal RxNorm lookup 1040058 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 64597-301-13 2025-11-10 These highlights do not include all the information needed to use NUEDEXTA safely and effectively. See full prescribing information for NUEDEXTA. NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, for oral use Initial U.S. Approval: 2010 64597-301-13 2025-11-10 These highlights do not include all the information needed to use NUEDEXTA safely and effectively. See full prescribing information for NUEDEXTA. NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, for oral use Initial U.S. Approval: 2010 64597-301-60 2025-11-10 These highlights do not include all the information needed to use NUEDEXTA safely and effectively. See full prescribing information for NUEDEXTA. NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, for oral use Initial U.S. Approval: 2010 64597-301-60 2025-11-10 These highlights do not include all the information needed to use NUEDEXTA safely and effectively. See full prescribing information for NUEDEXTA. NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, for oral use Initial U.S. Approval: 2010 64597-301-13 2025-01-30 These highlights do not include all the information needed to use NUEDEXTA safely and effectively. See full prescribing information for NUEDEXTA. NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, for oral use Initial U.S. Approval: 2010 64597-301-13 2025-01-30 These highlights do not include all the information needed to use NUEDEXTA safely and effectively. See full prescribing information for NUEDEXTA. NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, for oral use Initial U.S. Approval: 2010 64597-301-60 2025-01-30 These highlights do not include all the information needed to use NUEDEXTA safely and effectively. See full prescribing information for NUEDEXTA. NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, for oral use Initial U.S. Approval: 2010 64597-301-60 2025-01-30 These highlights do not include all the information needed to use NUEDEXTA safely and effectively. See full prescribing information for NUEDEXTA. NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, for oral use Initial U.S. Approval: 2010
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64597-301-13 NUEDEXTA 13 in 1 BOTTLE CAPSULE, GELATIN COATED 13 29 64597-301-13 NUEDEXTA 1 in 1 CARTON CAPSULE, GELATIN COATED 1 29 64597-301-60 NUEDEXTA 60 in 1 BOTTLE CAPSULE, GELATIN COATED 60 29
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.] 12 QUINIDINE SULFATE ACTIVE INGREDIENT J13S2394HE NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.] 12 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.] 12 QUINIDINE ACTIVE MOIETY ITX08688JL NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.] 12 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.] 12 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.] 12 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64597-301 NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [AVANIR PHARMACEUTICALS, INC.] 28 Current NDC, Legacy NDC, 3 package rows 20231208_484e0918-3442-49dc-8ccf-177f1f3ee9f3.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 Units Marketing start Marketing end Sample Exclude flag Status 64597-301-13 64597030113 1 BOTTLE in 1 CARTON (64597-301-13) / 13 CAPSULE, GELATIN COATED in 1 BOTTLE 1 bottle 2010-12-01 2026-08-13 No No Current 64597-301-60 64597030160 60 CAPSULE, GELATIN COATED in 1 BOTTLE (64597-301-60) 2010-12-01 2026-08-13 No No Current