Home NDC 68094-762 Midazolam Hydrochloride
Product NDC 68094-762
11-digit product format 680940762
Labeler code 68094
Product ID 68094-762_8b065244-dc26-4da0-9e51-42989976fdfb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Midazolam Hydrochloride
Dosage form SYRUP
Route ORAL
Labeler Precision Dose Inc.
Application ANDA075873
Marketing category ANDA
Marketing start 2015-05-26
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 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 A075873-001 MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075873-001 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 · 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 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075873-001 MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML SYRUP / ORAL AA RS 2002-04-30 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 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 68094-762-59 Midazolam Hydrochloride 2.5 mL in 1 CUP, UNIT-DOSE SYRUP 2.5 6 68094-762-62 Midazolam Hydrochloride 10 in 1 TRAY SYRUP 10 6 68094-762-62 Midazolam Hydrochloride 3 in 1 CASE SYRUP 3 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68094-762 MIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.] 5 Current NDC, Legacy NDC, 3 package rows 20250321_557ef7bf-9341-47f9-804d-430a24982fa6.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE American Health Packaging fc93242b-0abf-466a-8413-8a365620ee75 2026-07-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075873 application number: ANDA075873 Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE Precision Dose Inc. 9a443652-6aff-4e27-83fe-90c65fa0f3c1 2026-05-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075873 application number: ANDA075873 Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE Precision Dose Inc. 557ef7bf-9341-47f9-804d-430a24982fa6 2025-08-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075873 application number: ANDA075873 ndc (product): 68094-762 Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. a833c24b-6dca-44d7-a0d6-20012fa1ea77 2025-04-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 075873 application number: ANDA075873
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 68094-762-59 68094076259 2.5 mL in 1 CUP, UNIT-DOSE 2.5 ml Historical 68094-762-62 68094076262 3 TRAY in 1 CASE (68094-762-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 2.5 mL in 1 CUP, UNIT-DOSE (68094-762-59) 3 tray 2015-05-26 0000-00-00 No No Current