Home NDC 17856-3566-5 Midazolam Hydrochloride
Product NDC 17856-3566
Requested package NDC 17856-3566-5
11-digit product format 178563566
Labeler code 17856
Product ID 17856-3566_df782df5-b572-4a09-9015-29a41bda566c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Midazolam Hydrochloride
Dosage form SYRUP
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA075873
Marketing category ANDA
Marketing start 2002-04-30
Marketing end 0000-00-00
Substance MIDAZOLAM HYDROCHLORIDE
Active strength 2 mg/mL
Pharmacologic classes Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17856-3566 17856-3566-5 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-3566 17856-3566-5 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-3566-1 Midazolam Hydrochloride 2 mL in 1 CUP SYRUP 2 6 17856-3566-3 Midazolam Hydrochloride 5 mL in 1 CUP SYRUP 5 6 17856-3566-5 Midazolam Hydrochloride 5 mL in 1 SYRINGE SYRUP 5 6 17856-3566-5 Midazolam Hydrochloride 48 in 1 BOX, UNIT-DOSE SYRUP 48 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-3566 MIDAZOLAM HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORP.] 6 Legacy NDC, 4 package rows 20240522_e55d49cb-ef77-496f-b74d-05b69ff19df0.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 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 17856-3566-5 17856356605 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-3566-5) > 5 mL in 1 SYRINGE 48 syringe 2021-09-16 0000-00-00 No No Current