Home NDC 68083-619 Midazolam In Sodium Chloride
Product NDC 68083-619
11-digit product format 680830619
Labeler code 68083
Product ID 68083-619_fda891ec-dee1-4978-a550-8c10c1cf3d8c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Midazolam In Sodium Chloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA218993
Marketing category ANDA
Marketing start 2024-08-12
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 A218993-001 MIDAZOLAM IN 0.9% SODIUM CHLORIDE MIDAZOLAM 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 A218993-002 MIDAZOLAM IN 0.9% SODIUM CHLORIDE MIDAZOLAM 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12
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.
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 A218993-001 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218993-002 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218993-001 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218993-002 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218993-001 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218993-002 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218993-001 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218993-002 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218993-001 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218993-002 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218993-001 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218993-002 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218993-001 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218993-002 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218993-001 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218993-002 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218993-001 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218993-002 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218993-001 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218993-002 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218993-001 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218993-002 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218993-001 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 50MG/50ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218993-002 MIDAZOLAM IN 0.9% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Midazolam In Sodium Chloride
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 2541170 Internal RxNorm lookup 2541171 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 68083-619-10 Midazolam In Sodium Chloride 10 in 1 CARTON INJECTION, SOLUTION 10 5 68083-619-10 Midazolam In Sodium Chloride 1 in 1 POUCH INJECTION, SOLUTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-619 MIDAZOLAM IN SODIUM CHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED] 5 Current NDC, 2 package rows 20240817_9ba78a7c-5b05-42a3-89cd-ca51ad9b2e6d.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 68083-619-10 68083061910 10 POUCH in 1 CARTON (68083-619-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG 10 pouch 2024-08-12 No No Current