Home NDC 82449-207 Midazolam
Product NDC 82449-207
11-digit product format 824490207
Labeler code 82449
Product ID 82449-207_0c638f3c-bdd6-8385-e063-6394a90a53ef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name midazolam hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Steriscience Specialties Private Limited
Application ANDA090316
Marketing category ANDA
Marketing start 2023-07-31
Substance MIDAZOLAM HYDROCHLORIDE
Active strength 1 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090316-001 MIDOZALAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 A090316-002 MIDOZALAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04
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 3 · 84 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 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2011-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION 2011-05-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION 2011-05-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION 2011-05-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION 2011-05-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION 2011-05-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION 2011-05-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION 2011-05-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION 2011-05-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090316-001 MIDOZALAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION 2011-05-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090316-002 MIDOZALAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION 2011-05-04 bb7c543d1eb4…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Midazolam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIDAZOLAM HYDROCHLORIDE 1 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311700 Internal RxNorm lookup 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 82449-207-02 Midazolam 10 mL in 1 VIAL INJECTION, SOLUTION 10 14 82449-207-02 Midazolam 10 in 1 CARTON INJECTION, SOLUTION 10 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82449-207 MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [STERISCIENCE SPECIALTIES PRIVATE LIMITED] 14 Current NDC, 2 package rows 20231214_473fba4b-8754-4b1d-bba9-d9c8f6d818e0.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 · 3 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 82449-207-02 82449020702 10 VIAL in 1 CARTON (82449-207-02) / 10 mL in 1 VIAL 10 vial 2023-07-31 No No Current