Home DailyMed cdcc20c8-db29-43c9-aef2-f105e5b58878 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:42:04 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021879-001 NUEDEXTA 20MG;10MG CAPSULE / ORAL AB RLD, RS 2010-10-29 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 68 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NUEDEXTA DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE Avanir Pharmaceuticals, Inc. 484e0918-3442-49dc-8ccf-177f1f3ee9f3 2025-10-21 Warnings, Adverse reactions Exact identifier ndc (package): 64597-301-60 ndc11 (package): 64597030160
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.