Home NDC 0527-1767 Diazepam
Product NDC 0527-1767
11-digit product format 005271767
Labeler code 0527
Product ID 0527-1767_10af5f76-5a1d-440c-b2a7-a3597a5d5b7b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diazepam
Dosage form SOLUTION
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA206477
Marketing category ANDA
Marketing start 2016-06-24
Marketing end 0000-00-00
Substance DIAZEPAM
Active strength 5 mg/5mL
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0527-1767-65 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0527-1767-65 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0527-1767-65 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0527-1767-65 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0527-1767-65 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0527-1767-65 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0527-1767-65 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0527-1767-65 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0527-1767-65 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0527-1767-65 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0527-1767-65 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0527-1767-65 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206477-001 DIAZEPAM DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206477-001 AA
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 · 42 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 2026-08-18 06:07:40 2026-07 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206477-001 DIAZEPAM 5MG/5ML SOLUTION / ORAL AA 2016-06-24 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIAZEPAM ACTIVE INGREDIENT Q3JTX2Q7TU DIAZEPAM SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 17 DIAZEPAM ACTIVE MOIETY Q3JTX2Q7TU DIAZEPAM SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 17 ALCOHOL INACTIVE INGREDIENT 3K9958V90M DIAZEPAM SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 17 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 DIAZEPAM SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 17 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DIAZEPAM SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 17 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DIAZEPAM SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 17 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DIAZEPAM SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 17 SUCCINIC ACID INACTIVE INGREDIENT AB6MNQ6J6L DIAZEPAM SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 17 WATER INACTIVE INGREDIENT 059QF0KO0R DIAZEPAM SOLUTION, CONCENTRATE [LANNETT COMPANY, INC.] 17
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 Units Marketing start Marketing end Sample Exclude flag Status 0527-1767-65 00527176765 500 mL in 1 BOTTLE, PLASTIC (0527-1767-65) 500 ml 2016-06-24 0000-00-00 No No Current