Home NDC 0527-1971 cocaine hydrochloride nasal
Product NDC 0527-1971
11-digit product format 005271971
Labeler code 0527
Product ID 0527-1971_a4c41af2-e18e-4f1f-bd27-a5f38f4a4ede
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cocaine hydrochloride nasal
Dosage form SOLUTION
Route TOPICAL
Labeler Lannett Company, Inc.
Application NDA209575
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2020-01-10
Marketing end 0000-00-00
Substance COCAINE HYDROCHLORIDE
Active strength 40 mg/mL
DEA schedule CII
NDC exclude flag No
Listing certified through 2023-12-31
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 · 34 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 N209575-001 NUMBRINO COCAINE HYDROCHLORIDE 4% SOLUTION / NASAL RLD, RS 2020-01-10
Orange Book patents# Current patent rows page 1 of 1 · 18 matching rows.
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.
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 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209575-001 NUMBRINO 4% SOLUTION / NASAL 2020-01-10 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 10 · 378 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N209575-001 10016407 2037-02-07 U-2225 2023-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209575-001 10016407 2037-02-07 U-2226 2023-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209575-001 10016407 2037-02-07 U-2329 2023-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209575-001 10149843 2037-02-07 U-2478 2023-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209575-001 10149843 2037-02-07 U-2479 2023-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209575-001 10231961 2037-02-07 Drug product 2023-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209575-001 10413505 2037-02-07 U-3014 2023-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209575-001 10420760 2037-02-07 U-2478 2023-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209575-001 10857095 2037-02-07 U-3014 2023-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209575-001 10894012 2037-02-07 U-3014 2023-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209575-001 10933060 2037-02-07 U-2478 2023-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209575-001 10933060 2037-02-07 U-3014 2023-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209575-001 10973811 2037-02-07 U-3680 2023-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209575-001 11040032 2037-02-07 Drug product 2023-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209575-001 9867815 2037-02-07 U-2225 2023-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209575-001 9867815 2037-02-07 U-2329 2023-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209575-001 9867815 2037-02-07 U-2227 2023-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209575-001 9867815 2037-02-07 U-2226 2023-08-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209575-001 10016407 2037-02-07 U-2225 2023-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209575-001 10016407 2037-02-07 U-2226 2023-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209575-001 10016407 2037-02-07 U-2329 2023-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209575-001 10149843 2037-02-07 U-2478 2023-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209575-001 10149843 2037-02-07 U-2479 2023-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209575-001 10231961 2037-02-07 Drug product 2023-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209575-001 10413505 2037-02-07 U-3014 2023-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209575-001 10420760 2037-02-07 U-2478 2023-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209575-001 10857095 2037-02-07 U-3014 2023-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209575-001 10894012 2037-02-07 U-3014 2023-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209575-001 10933060 2037-02-07 U-2478 2023-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209575-001 10933060 2037-02-07 U-3014 2023-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209575-001 10973811 2037-02-07 U-3680 2023-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209575-001 11040032 2037-02-07 Drug product 2023-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209575-001 9867815 2037-02-07 U-2225 2023-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209575-001 9867815 2037-02-07 U-2329 2023-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209575-001 9867815 2037-02-07 U-2227 2023-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209575-001 9867815 2037-02-07 U-2226 2023-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209575-001 10016407 2037-02-07 U-2225 2023-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209575-001 10016407 2037-02-07 U-2226 2023-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209575-001 10016407 2037-02-07 U-2329 2023-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209575-001 10149843 2037-02-07 U-2478 2023-08-28 31067a03dcf5…
Observed Orange Book exclusivity history# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0527-1971-73 00527197173 1 BOTTLE, GLASS in 1 CARTON (0527-1971-73) > 10 mL in 1 BOTTLE, GLASS 2020-01-10 0000-00-00 No No Current 0527-1971-74 00527197174 1 BOTTLE, GLASS in 1 CARTON (0527-1971-74) > 4 mL in 1 BOTTLE, GLASS 2020-01-10 0000-00-00 No No Current