Home NDC 0054-3185 Diazepam Intensol
Product NDC 0054-3185
11-digit product format 000543185
Labeler code 0054
Product ID 0054-3185_ab533d6f-4e34-4675-9da6-b93484134aca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diazepam Intensol
Dosage form SOLUTION, CONCENTRATE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA071415
Marketing category ANDA
Marketing start 1987-04-03
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 A071415-001 DIAZEPAM INTENSOL DIAZEPAM 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071415-001 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 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL RS 1987-04-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL RS 1987-04-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL RS 1987-04-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL RS 1987-04-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL AA RS 1987-04-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A071415-001 DIAZEPAM INTENSOL 5MG/ML CONCENTRATE / ORAL RS 1987-04-03 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Diazepam Intensol
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 0054-3185-44 Diazepam Intensol 1 in 1 CARTON SOLUTION, CONCENTRATE 1 13 0054-3185-44 Diazepam Intensol 30 mL in 1 BOTTLE SOLUTION, CONCENTRATE 30 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIAZEPAM ACTIVE INGREDIENT Q3JTX2Q7TU DIAZEPAM SOLUTION DIAZEPAM INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 3 DIAZEPAM ACTIVE MOIETY Q3JTX2Q7TU DIAZEPAM SOLUTION DIAZEPAM INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 3 ALCOHOL INACTIVE INGREDIENT 3K9958V90M DIAZEPAM SOLUTION DIAZEPAM INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL DIAZEPAM SOLUTION DIAZEPAM INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DIAZEPAM SOLUTION DIAZEPAM INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DIAZEPAM SOLUTION DIAZEPAM INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 3 POLYETHYLENE GLYCOL 1000 INACTIVE INGREDIENT U076Q6Q621 DIAZEPAM SOLUTION DIAZEPAM INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ DIAZEPAM SOLUTION DIAZEPAM INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DIAZEPAM SOLUTION DIAZEPAM INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 3 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR DIAZEPAM SOLUTION DIAZEPAM INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R DIAZEPAM SOLUTION DIAZEPAM INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 3 SUCCINIC ACID INACTIVE INGREDIENT AB6MNQ6J6L DIAZEPAM SOLUTION DIAZEPAM INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 3 WATER INACTIVE INGREDIENT 059QF0KO0R DIAZEPAM SOLUTION DIAZEPAM INTENSOL SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-3185 DIAZEPAM INTENSOL SOLUTION, CONCENTRATE [HIKMA PHARMACEUTICALS USA INC.] 13 Current NDC, Legacy NDC, 2 package rows 20241212_1aaf9375-ae3d-4fed-9cd1-24102e00be1a.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 0054-3185-44 00054318544 1 BOTTLE in 1 CARTON (0054-3185-44) / 30 mL in 1 BOTTLE 1 bottle 1987-04-03 0000-00-00 No No Current