Home NDC 0378-4415-01 Flurazepam Hydrochloride
Product NDC 0378-4415
Requested package NDC 0378-4415-01
11-digit product format 003784415
Labeler code 0378
Product ID 0378-4415_66fa1d6a-ee0e-4145-b5fc-52a12f7d0c95
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name flurazepam hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA070345
Marketing category ANDA
Marketing start 1985-11-27
Marketing end 2023-01-31
Substance FLURAZEPAM HYDROCHLORIDE
Active strength 15 mg/1
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070345-001 FLURAZEPAM HYDROCHLORIDE FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 A070345-002 FLURAZEPAM HYDROCHLORIDE FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
Product history page 1 of 3 · 86 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 2026-09-14 22:38:34 2026-08 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL AB RS 1985-11-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL AB 1985-11-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL RS 1985-11-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL 1985-11-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL RS 1985-11-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL 1985-11-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL RS 1985-11-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL 1985-11-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070345-001 FLURAZEPAM HYDROCHLORIDE 30MG CAPSULE / ORAL RS 1985-11-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A070345-002 FLURAZEPAM HYDROCHLORIDE 15MG CAPSULE / ORAL 1985-11-27 74a2ff9319b5…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FLURAZEPAM HYDROCHLORIDE ACTIVE INGREDIENT 756RDM536M FLURAZEPAM HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 8 FLURAZEPAM ACTIVE MOIETY IHP475989U FLURAZEPAM HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLURAZEPAM HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 8 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FLURAZEPAM HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 8 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FLURAZEPAM HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 8 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK FLURAZEPAM HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 8 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY FLURAZEPAM HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 8 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FLURAZEPAM HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 8 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 FLURAZEPAM HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 8 GELATIN INACTIVE INGREDIENT 2G86QN327L FLURAZEPAM HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLURAZEPAM HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 8 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M FLURAZEPAM HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 8 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FLURAZEPAM HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 8 SHELLAC INACTIVE INGREDIENT 46N107B71O FLURAZEPAM HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLURAZEPAM HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 8 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FLURAZEPAM HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLURAZEPAM HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] 8 FLURAZEPAM HYDROCHLORIDE ACTIVE INGREDIENT 756RDM536M FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 FLURAZEPAM ACTIVE MOIETY IHP475989U FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLURAZEPAM HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-4415-01 00378441501 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-4415-01) 100 capsule 1985-11-27 2023-01-31 No No Current