Home NDC 63323-411 Midazolam
Product NDC 63323-411
11-digit product format 633230411
Labeler code 63323
Product ID 63323-411_9814447b-a93e-42ad-b57e-5db0a5b7f552
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MIDAZOLAM HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA075154
Marketing category ANDA
Marketing start 2000-07-14
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 A075154-001 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 A075154-002 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20
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 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075154-001 MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075154-002 MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE / INJECTION AP 2000-06-20 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 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 63323-411-10 Midazolam 10 in 1 TRAY INJECTION, SOLUTION 10 7 63323-411-12 Midazolam 25 in 1 TRAY INJECTION, SOLUTION 25 7 63323-411-13 Midazolam 10 mL in 1 VIAL INJECTION, SOLUTION 10 7 63323-411-15 Midazolam 2 mL in 1 VIAL INJECTION, SOLUTION 2 7 63323-411-18 Midazolam 5 mL in 1 VIAL INJECTION, SOLUTION 5 7 63323-411-22 Midazolam 2 mL in 1 VIAL INJECTION, SOLUTION 2 7 63323-411-25 Midazolam 25 in 1 TRAY INJECTION, SOLUTION 25 7 63323-411-27 Midazolam 25 in 1 TRAY INJECTION, SOLUTION 25 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MIDAZOLAM HYDROCHLORIDE ACTIVE INGREDIENT W7TTW573JJ MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 MIDAZOLAM ACTIVE MOIETY R60L0SM5BC MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-411 MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 7 Current NDC, Legacy NDC, 8 package rows 20240806_a91ce254-14a3-4cbf-8ab8-5da252aa3fdc.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Midazolam MIDAZOLAM HYDROCHLORIDE Fresenius Kabi USA, LLC a91ce254-14a3-4cbf-8ab8-5da252aa3fdc 2024-07-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075154 application number: ANDA075154 ndc (product): 63323-411
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-411-10 63323041110 10 VIAL in 1 TRAY (63323-411-10) / 10 mL in 1 VIAL (63323-411-13) 10 vial 2000-07-14 0000-00-00 No No Current 63323-411-12 63323041112 25 VIAL in 1 TRAY (63323-411-12) / 2 mL in 1 VIAL (63323-411-15) 25 vial 2000-07-14 0000-00-00 No No Current 63323-411-13 63323041113 10 mL in 1 VIAL 10 ml Historical 63323-411-15 63323041115 2 mL in 1 VIAL 2 ml Historical 63323-411-18 63323041118 5 mL in 1 VIAL 5 ml Historical 63323-411-22 63323041122 2 mL in 1 VIAL 2 ml Historical 63323-411-25 63323041125 25 VIAL in 1 TRAY (63323-411-25) / 5 mL in 1 VIAL (63323-411-18) 25 vial 2000-07-14 0000-00-00 No No Current 63323-411-27 63323041127 25 VIAL in 1 TRAY (63323-411-27) / 2 mL in 1 VIAL (63323-411-22) 25 vial 2025-01-06 No No Current