Flurazepam

Product NDC
0143-3370
11-digit product format
001433370
Labeler code
0143
Product ID
0143-3370_3897b6f0-5a9e-4ea1-8f4e-c8cc47547d19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flurazepam Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
West-ward Pharmaceutical Corp
Application
ANDA071108
Marketing category
ANDA
Marketing start
1986-12-08
Marketing end
0000-00-00
Substance
FLURAZEPAM HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0143-3370DDiscontinued by firm2026-10-05
excluded packagepackage0143-33700143-3370-01DDiscontinued by firm2026-10-05
excluded packagepackage0143-33700143-3370-05DDiscontinued by firm2026-10-05
excluded packagepackage0143-33700143-3370-30DDiscontinued by firm2026-10-05

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 · 48 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 packagepackage0143-3370-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0143-3370-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0143-3370-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-3370-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-3370-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0143-3370-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-3370-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-3370-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0143-3370-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-3370-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-3370-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0143-3370-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-3370-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-3370-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0143-3370-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-3370-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-3370-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0143-3370-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-3370-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-3370-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0143-3370-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-3370-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-3370-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0143-3370-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-3370-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-3370-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0143-3370-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-3370-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-3370-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0143-3370-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-3370-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-3370-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0143-3370-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-3370-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-3370-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0143-3370-30557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071108-001FLURAZEPAM HYDROCHLORIDEFLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-08
A071108-002FLURAZEPAM HYDROCHLORIDEFLURAZEPAM HYDROCHLORIDE15MGCAPSULE / ORAL1986-12-08

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 · 46 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-0884e616aacf4f…
2026-09-14 22:38:342026-08A071108-002FLURAZEPAM HYDROCHLORIDE15MGCAPSULE / ORAL1986-12-0884e616aacf4f…
2026-08-18 06:07:402026-07A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A071108-002FLURAZEPAM HYDROCHLORIDE15MGCAPSULE / ORAL1986-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-083f01610625f2…
2019-09-15 20:21 UTC2019-09A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A071108-001FLURAZEPAM HYDROCHLORIDE30MGCAPSULE / ORAL1986-12-083bdfa0b2c4d7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
af12b19d-88f8-90fa-798d-f1e0ce812052Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-3370-01EA - Each0143-33700348296a-449f-486f-b0be-1deb3d3a78ae12012-07-24
0143-3370-05EA - Each0143-3370d0cecd2c-79e3-475f-bc7e-16fa3dfd50ac12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLURAZEPAM HYDROCHLORIDEACTIVE INGREDIENT756RDM536MFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
FLURAZEPAMACTIVE MOIETYIHP475989UFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [H.J. HARKINS COMPANY, INC.]2
FLURAZEPAM HYDROCHLORIDEACTIVE INGREDIENT756RDM536MFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
FLURAZEPAMACTIVE MOIETYIHP475989UFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLURAZEPAM (FLURAZEPAM HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298091flurazepam HCl 30 MG Oral CapsulePSN50453bda-bf59-4f1e-bf36-bc3f039b28572
1298091flurazepam hydrochloride 30 MG Oral CapsuleSCD50453bda-bf59-4f1e-bf36-bc3f039b28572
1298091flurazepam HCl 30 MG Oral CapsulePSN16a5de2d-2f89-4fc2-a1cf-2d6fd11f27481
1298091flurazepam hydrochloride 30 MG Oral CapsuleSCD16a5de2d-2f89-4fc2-a1cf-2d6fd11f27481