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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0527-1971DDiscontinued by firm2026-08-17
excluded packagepackage0527-19710527-1971-73DDiscontinued by firm2026-08-17
excluded packagepackage0527-19710527-1971-74DDiscontinued by firm2026-08-17

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.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0527-1971-74d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0527-1971-73d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0527-1971-74f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0527-1971-73f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0527-1971-742ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0527-1971-732ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0527-1971-74a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0527-1971-73a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0527-1971-74cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0527-1971-73cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0527-1971-74cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0527-1971-73cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0527-1971-74302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0527-1971-73302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0527-1971-74ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0527-1971-73ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0527-1971-740efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0527-1971-730efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0527-1971-74ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0527-1971-73ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0527-1971-74367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0527-1971-73367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0527-1971-73557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209575-001NUMBRINOCOCAINE HYDROCHLORIDE4%SOLUTION / NASALRLD, RS2020-01-10

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209575-001100164072037-02-07U-22252023-08-28
N209575-001100164072037-02-07U-22262023-08-28
N209575-001100164072037-02-07U-23292023-08-28
N209575-001101498432037-02-07U-24782023-08-28
N209575-001101498432037-02-07U-24792023-08-28
N209575-001102319612037-02-07Drug product2023-08-28
N209575-001104135052037-02-07U-30142023-08-28
N209575-001104207602037-02-07U-24782023-08-28
N209575-001108570952037-02-07U-30142023-08-28
N209575-001108940122037-02-07U-30142023-08-28
N209575-001109330602037-02-07U-24782023-08-28
N209575-001109330602037-02-07U-30142023-08-28
N209575-001109738112037-02-07U-36802023-08-28
N209575-001110400322037-02-07Drug product2023-08-28
N209575-00198678152037-02-07U-22252023-08-28
N209575-00198678152037-02-07U-22262023-08-28
N209575-00198678152037-02-07U-22272023-08-28
N209575-00198678152037-02-07U-23292023-08-28

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-104b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-1087673890dc5c…
2021-03-12 10:30 UTC2021-03N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209575-001NUMBRINO4%SOLUTION / NASAL2020-01-10c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-103f0d92c62455…
2023-05-13 08:27 UTC2023-05N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10053a50430f4f…
2023-01-26 05:58 UTC2023-01N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N209575-001NUMBRINO4%SOLUTION / NASALRLD, RS2020-01-10a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 10 · 378 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N209575-001100164072037-02-07U-22252023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001100164072037-02-07U-22262023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001100164072037-02-07U-23292023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001101498432037-02-07U-24782023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001101498432037-02-07U-24792023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001102319612037-02-07Drug product2023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001104135052037-02-07U-30142023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001104207602037-02-07U-24782023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001108570952037-02-07U-30142023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001108940122037-02-07U-30142023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001109330602037-02-07U-24782023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001109330602037-02-07U-30142023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001109738112037-02-07U-36802023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-001110400322037-02-07Drug product2023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-00198678152037-02-07U-22252023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-00198678152037-02-07U-23292023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-00198678152037-02-07U-22272023-08-28caaa826d4ba7…
2026-08-18 06:07:402026-07N209575-00198678152037-02-07U-22262023-08-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209575-001100164072037-02-07U-22252023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001100164072037-02-07U-22262023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001100164072037-02-07U-23292023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001101498432037-02-07U-24782023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001101498432037-02-07U-24792023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001102319612037-02-07Drug product2023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001104135052037-02-07U-30142023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001104207602037-02-07U-24782023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001108570952037-02-07U-30142023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001108940122037-02-07U-30142023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001109330602037-02-07U-24782023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001109330602037-02-07U-30142023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001109738112037-02-07U-36802023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-001110400322037-02-07Drug product2023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-00198678152037-02-07U-22252023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-00198678152037-02-07U-23292023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-00198678152037-02-07U-22272023-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209575-00198678152037-02-07U-22262023-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209575-001100164072037-02-07U-22252023-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209575-001100164072037-02-07U-22262023-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209575-001100164072037-02-07U-23292023-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209575-001101498432037-02-07U-24782023-08-2831067a03dcf5…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209575-001NCE2022-12-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209575-001NP2023-01-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209575-001NCE2022-12-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N209575-001NP2023-01-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209575-001NCE2022-12-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N209575-001NP2023-01-104b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N209575-001NCE2022-12-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N209575-001NP2023-01-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209575-001NCE2022-12-14782e0a99824c…
2021-12-28 21:50 UTC2021-12N209575-001NP2023-01-10782e0a99824c…
2023-12-20 04:57 UTC2023-12N209575-001NP2023-01-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209575-001NP2023-01-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209575-001NP2023-01-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209575-001NP2023-01-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209575-001NP2023-01-103f0d92c62455…
2023-05-13 08:27 UTC2023-05N209575-001NP2023-01-10053a50430f4f…
2023-01-26 05:58 UTC2023-01N209575-001NCE2022-12-143bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N209575-001NP2023-01-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209575-001NCE2022-12-143a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209575-001NP2023-01-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N209575-001NCE2022-12-14f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N209575-001NP2023-01-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209575-001NCE2022-12-14e64feba35796…
2022-09-29 23:25 UTC2022-09N209575-001NP2023-01-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209575-001NCE2022-12-14cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N209575-001NP2023-01-10cb3db0bc1861…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUMBRINOCOCAINE HYDROCHLORIDE NASALOMNIVIUM PHARMACEUTICALS LLC.d724b5b4-6654-4bf5-9eed-e2c7943084ed2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 209575
application number: NDA209575
cocaine hydrochloride nasalCOCAINE HYDROCHLORIDE NASALOMNIVIUM PHARMACEUTICALS LLC.4e3b2f6b-1b57-40bc-872b-01c0a3c7986e2023-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 209575
application number: NDA209575

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0527-1971-73005271971731 BOTTLE, GLASS in 1 CARTON (0527-1971-73) > 10 mL in 1 BOTTLE, GLASS2020-01-100000-00-00NoNoCurrent
0527-1971-74005271971741 BOTTLE, GLASS in 1 CARTON (0527-1971-74) > 4 mL in 1 BOTTLE, GLASS2020-01-100000-00-00NoNoCurrent