Home NDC 0187-0658-20 Diastat
Product NDC 0187-0658
Requested package NDC 0187-0658-20
11-digit product format 001870658
Labeler code 0187
Product ID 0187-0658_1e7e58ee-24d8-4c34-8e85-7f3a8b425e01
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diazepam
Dosage form GEL
Route RECTAL
Labeler Bausch Health US, LLC
Application NDA020648
Marketing category NDA
Marketing start 1997-07-29
Marketing end 0000-00-00
Substance DIAZEPAM
Active strength 10 mg/2mL
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
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N020648-002 DIASTAT DIAZEPAM 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GEL / RECTAL RLD 1997-07-29 N020648-003 DIASTAT DIAZEPAM 10MG/2ML (5MG/ML) **Federal Register determination that product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.
DailyMed Socrata Ingredients# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diazepam DIAZEPAM Oceanside Pharmaceuticals b1b2848b-b265-4f6f-9141-bf106dec0726 2024-01-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020648 application number: NDA020648
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0187-0658-20 00187065820 2 SYRINGE, PLASTIC in 1 PACKAGE (0187-0658-20) > 2 mL in 1 SYRINGE, PLASTIC 1997-07-29 0000-00-00 No No Current