Home NDC 68475-804 Diazepam
Product NDC 68475-804
11-digit product format 684750804
Labeler code 68475
Product ID 68475-804_a3cf4952-5564-4a2b-81f3-148d441c30ee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diazepam
Dosage form GEL
Route RECTAL
Labeler Navinta LLC
Application ANDA217468
Marketing category ANDA
Marketing start 2026-02-06
Substance DIAZEPAM
Active strength 20 mg/4mL
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2027-12-31
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217468-001 DIAZEPAM DIAZEPAM 2.5MG/0.5ML (5MG/ML) GEL / RECTAL AB 2025-11-14 A217468-002 DIAZEPAM DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2025-11-14 A217468-003 DIAZEPAM DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2025-11-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
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 A217468-001 DIAZEPAM 2.5MG/0.5ML (5MG/ML) GEL / RECTAL AB 2025-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217468-002 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2025-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217468-003 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2025-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217468-001 DIAZEPAM 2.5MG/0.5ML (5MG/ML) GEL / RECTAL AB 2025-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217468-002 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2025-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217468-003 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2025-11-14 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217468-001 DIAZEPAM 2.5MG/0.5ML (5MG/ML) GEL / RECTAL AB 2025-11-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217468-002 DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB 2025-11-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217468-003 DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB 2025-11-14 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Diazepam
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIAZEPAM 20 mg/4mL
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 801957 Internal RxNorm lookup 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 68475-804-02 Diazepam 4 mL in 1 SYRINGE, PLASTIC GEL 4 2 68475-804-02 Diazepam 2 in 1 PACKAGE GEL 2 2
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 Marketing start Sample Exclude flag Status 68475-804-02 68475080402 2 SYRINGE, PLASTIC in 1 PACKAGE (68475-804-02) / 4 mL in 1 SYRINGE, PLASTIC 2026-02-06 No No Current