Home NDC 68682-652 Diazepam
Product NDC 68682-652
11-digit product format 686820652
Labeler code 68682
Product ID 68682-652_0e23d654-d8b9-af1c-e063-6294a90a6f14
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diazepam
Dosage form GEL
Route RECTAL
Labeler Oceanside Pharmaceuticals
Application NDA020648
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1997-07-29
Substance DIAZEPAM
Active strength 10 mg/2mL
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 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020648-001 DIASTAT DIAZEPAM 2.5MG/0.5ML (5MG/ML) GEL / RECTAL AB RLD, RS 1997-07-29 N020648-002 DIASTAT DIAZEPAM 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 N020648-003 DIASTAT DIAZEPAM 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 N020648-004 DIASTAT DIAZEPAM 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 N020648-005 DIASTAT DIAZEPAM 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 N020648-006 DIASTAT ACUDIAL DIAZEPAM 20MG/4ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 N020648-007 DIASTAT ACUDIAL DIAZEPAM 10MG/2ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15
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.
Product history page 1 of 8 · 287 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 N020648-001 DIASTAT 2.5MG/0.5ML (5MG/ML) GEL / RECTAL AB RLD, RS 1997-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020648-002 DIASTAT 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020648-003 DIASTAT 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020648-004 DIASTAT 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020648-005 DIASTAT 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020648-006 DIASTAT ACUDIAL 20MG/4ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020648-007 DIASTAT ACUDIAL 10MG/2ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020648-001 DIASTAT 2.5MG/0.5ML (5MG/ML) GEL / RECTAL AB RLD, RS 1997-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020648-002 DIASTAT 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020648-003 DIASTAT 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020648-004 DIASTAT 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020648-005 DIASTAT 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020648-006 DIASTAT ACUDIAL 20MG/4ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020648-007 DIASTAT ACUDIAL 10MG/2ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020648-001 DIASTAT 2.5MG/0.5ML (5MG/ML) GEL / RECTAL RLD, RS 1997-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020648-002 DIASTAT 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020648-003 DIASTAT 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020648-004 DIASTAT 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020648-005 DIASTAT 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020648-006 DIASTAT ACUDIAL 20MG/4ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020648-007 DIASTAT ACUDIAL 10MG/2ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020648-001 DIASTAT 2.5MG/0.5ML (5MG/ML) GEL / RECTAL RLD, RS 1997-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020648-002 DIASTAT 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020648-003 DIASTAT 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020648-004 DIASTAT 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020648-005 DIASTAT 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020648-006 DIASTAT ACUDIAL 20MG/4ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020648-007 DIASTAT ACUDIAL 10MG/2ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020648-001 DIASTAT 2.5MG/0.5ML (5MG/ML) GEL / RECTAL RLD, RS 1997-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020648-002 DIASTAT 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020648-003 DIASTAT 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020648-004 DIASTAT 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020648-005 DIASTAT 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020648-006 DIASTAT ACUDIAL 20MG/4ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020648-007 DIASTAT ACUDIAL 10MG/2ML (5MG/ML) GEL / RECTAL AB RLD, RS 2005-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020648-001 DIASTAT 2.5MG/0.5ML (5MG/ML) GEL / RECTAL RLD, RS 1997-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020648-002 DIASTAT 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020648-003 DIASTAT 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020648-004 DIASTAT 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020648-005 DIASTAT 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 47 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 10 mg/2mL
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 68682-652-20 Diazepam 2 mL in 1 SYRINGE, PLASTIC GEL 2 6 68682-652-20 Diazepam 2 in 1 PACKAGE GEL 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68682-652 DIAZEPAM GEL DIAZEPAM GEL [OCEANSIDE PHARMACEUTICALS] 6 Current NDC, Legacy NDC, 2 package rows 20240105_b1b2848b-b265-4f6f-9141-bf106dec0726.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 Marketing start Marketing end Sample Exclude flag Status 68682-652-20 68682065220 2 SYRINGE, PLASTIC in 1 PACKAGE (68682-652-20) / 2 mL in 1 SYRINGE, PLASTIC 1997-07-29 0000-00-00 No No Current