Home NDC 59148-053-16 Nuedexta
Product NDC 59148-053
Requested package NDC 59148-053-16
11-digit product format 591480053
Labeler code 59148
Product ID 59148-053_b73848d5-ceb2-482a-99bd-a2b6b895abae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dextromethorphan hydrobromide and quinidine sulfate
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Otsuka America Pharmaceutical, Inc
Application NDA021879
Marketing category NDA
Marketing start 2023-01-03
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 2027-12-31
Current FDA listing Yes 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 2027-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59148-053-07 Nuedexta 13 in 1 BOTTLE CAPSULE, GELATIN COATED 13 4 59148-053-07 Nuedexta 1 in 1 CARTON CAPSULE, GELATIN COATED 1 4 59148-053-16 Nuedexta 60 in 1 BOTTLE CAPSULE, GELATIN COATED 60 4 59148-053-98 Nuedexta 4 in 1 BOX CAPSULE, GELATIN COATED 4 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59148-053 NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE) CAPSULE, GELATIN COATED [OTSUKA AMERICA PHARMACEUTICAL, INC] 3 Current NDC, Legacy NDC, 4 package rows 20241204_c8cce784-8c5f-415b-8068-76e5d481d159.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 59148-053-16 59148005316 60 CAPSULE, GELATIN COATED in 1 BOTTLE (59148-053-16) 2023-01-03 0000-00-00 No No Current