Home NDC 62135-768 Diazepam
Product NDC 62135-768
11-digit product format 621350768
Labeler code 62135
Product ID 62135-768_4517b811-0a91-89f5-e063-6294a90a9a30
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diazepam Oral Solution (Concentrate)
Dosage form SOLUTION
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA204433
Marketing category ANDA
Marketing start 2014-04-14
Substance DIAZEPAM
Active strength 5 mg/mL
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A204433-001 DIAZEPAM DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204433-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL 2014-04-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL 2014-04-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL 2014-04-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL 2014-04-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA 2014-04-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204433-001 DIAZEPAM 5MG/ML CONCENTRATE / ORAL 2014-04-14 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Diazepam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIAZEPAM 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q3JTX2Q7TU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309843 Internal RxNorm lookup 309844 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-768-43 Diazepam 30 mL in 1 BOTTLE SOLUTION 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-768 DIAZEPAM (DIAZEPAM ORAL SOLUTION (CONCENTRATE)) SOLUTION DIAZEPAM (DIAZEPAM ORAL) SOLUTION [CHARTWELL RX, LLC] 4 Current NDC, Legacy NDC, 1 package rows 20241024_cdb839fb-27e5-4a11-aed6-da0a7ab6e996.zip
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 · 1 matching rows.
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 62135-768-43 62135076843 30 mL in 1 BOTTLE (62135-768-43) 30 ml 2022-08-17 0000-00-00 No No Current