Home NDC 25021-661 midazolam
Product NDC 25021-661
11-digit product format 250210661
Labeler code 25021
Product ID 25021-661_002ea282-09ba-4d79-8bd1-94c9859f442b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name midazolam hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA090850
Marketing category ANDA
Marketing start 2012-03-19
Substance MIDAZOLAM HYDROCHLORIDE
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 42 .
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 A090850-001 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090850-001 AP
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 · 42 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 2026-08-18 06:07:40 2026-07 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090850-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2012-01-25 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base midazolam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIDAZOLAM HYDROCHLORIDE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W7TTW573JJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311702 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 25021-661-10 midazolam 10 mL in 1 VIAL INJECTION, SOLUTION 10 14 25021-661-10 midazolam 10 in 1 CARTON INJECTION, SOLUTION 10 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-661 MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 14 Current NDC, 2 package rows 20231108_880cac48-5c0f-49a9-8aef-3c9770bf5d84.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE Jvet Pharmaceuticals LLC a84ddd02-1f5f-4311-9dae-2a5cb4064bf3 2025-12-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090850 application number: ANDA090850 Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE Belcher Pharmaceuticals, LLC cee4cdd0-58c5-4704-9fb6-d4bffb1764a8 2025-02-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090850 application number: ANDA090850 midazolam MIDAZOLAM HYDROCHLORIDE Sagent Pharmaceuticals 880cac48-5c0f-49a9-8aef-3c9770bf5d84 2023-11-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090850 application number: ANDA090850 ndc (product): 25021-661 Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE Gland Pharma Limited 81b2f48d-a05c-4301-8fee-761af220d44f 2023-10-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090850 application number: ANDA090850 Midazolam hydrochloride MIDAZOLAM HYDROCHLORIDE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 843cc25e-45ea-4372-ae34-843f805fa869 2023-03-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090850 application number: ANDA090850
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 25021-661-10 25021066110 10 VIAL in 1 CARTON (25021-661-10) / 10 mL in 1 VIAL 10 vial 2012-03-19 No No Current