Home NDC 43386-281 Diazepam
Product NDC 43386-281
11-digit product format 433860281
Labeler code 43386
Product ID 43386-281_91b10d2a-111a-4f2b-8b9a-d9c5d4a783f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diazepam
Dosage form GEL
Route RECTAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA091076
Marketing category ANDA
Marketing start 2023-10-30
Substance DIAZEPAM
Active strength 20 mg/4g
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091076-001 DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 A091076-002 DIAZEPAM DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30
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 2 · 44 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 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091076-001 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2023-05-30 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091076-002 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2023-05-30 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Diazepam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIAZEPAM 20 mg/4g
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 801961 Internal RxNorm lookup 801966 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 43386-281-01 Diazepam 2 in 1 PACKAGE GEL 2 8 43386-281-02 Diazepam 1 in 1 CARTON GEL 1 8 43386-281-03 Diazepam 4 g in 1 SYRINGE GEL 4 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-281 DIAZEPAM GEL [LUPIN PHARMACEUTICALS,INC.] 7 Current NDC, 3 package rows 20231216_d99b68aa-b3dc-49c8-8894-3da255cd26b0.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 Sample Exclude flag Status 43386-281-01 43386028101 2 in 1 PACKAGE Historical 43386-281-02 43386028102 1 PACKAGE in 1 CARTON (43386-281-02) / 2 SYRINGE in 1 PACKAGE (43386-281-01) / 4 g in 1 SYRINGE (43386-281-03) 1 package 2023-10-30 Yes No Current 43386-281-03 43386028103 4 g in 1 SYRINGE 4 g Historical