Home NDC 0574-0150 Midazolam Hydrochloride
Product NDC 0574-0150
11-digit product format 005740150
Labeler code 0574
Product ID 0574-0150_d7b8dd9f-1acd-4d10-afbf-a57a93154a6b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Midazolam Hydrochloride
Dosage form SYRUP
Route ORAL
Labeler Padagis US LLC
Application ANDA076379
Marketing category ANDA
Marketing start 2005-05-02
Substance MIDAZOLAM HYDROCHLORIDE
Active strength 2 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 1 .
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 A076379-001 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076379-001 AA
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 · 41 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 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076379-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA 2005-05-02 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Midazolam Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIDAZOLAM HYDROCHLORIDE 2 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 422410 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 0574-0150-04 Midazolam Hydrochloride 1 in 1 CARTON SYRUP 1 14 0574-0150-04 Midazolam Hydrochloride 118 mL in 1 BOTTLE, GLASS SYRUP 118 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Midazolam Hydrochloride ACTIVE INGREDIENT W7TTW573JJ MIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC] 6 Midazolam ACTIVE MOIETY R60L0SM5BC MIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC] 6 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL MIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC] 6 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L MIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC] 6 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K MIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC] 6 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX MIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC] 6 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB MIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC] 6 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU MIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC] 6 SORBITOL INACTIVE INGREDIENT 506T60A25R MIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC] 6 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K MIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC] 6 WATER INACTIVE INGREDIENT 059QF0KO0R MIDAZOLAM HYDROCHLORIDE SYRUP [PADDOCK LABORATORIES, LLC] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0574-0150 MIDAZOLAM HYDROCHLORIDE SYRUP [PADAGIS US LLC] 14 Current NDC, Legacy NDC, 2 package rows 20221211_0be63f63-6a93-4782-8f9c-d13ca5ae44bd.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 · 2 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 0574-0150-04 00574015004 1 BOTTLE, GLASS in 1 CARTON (0574-0150-04) / 118 mL in 1 BOTTLE, GLASS 2005-05-02 0000-00-00 No No Current