midazolam hydrochloride

Generic: midazolam hydrochloride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midazolam hydrochloride
Generic Name midazolam hydrochloride
Labeler american health packaging
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

midazolam hydrochloride 2 mg/mL

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-576
Product ID 60687-576_34f38926-e4e4-8bae-e063-6394a90a60ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075873
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2021-06-15

Pharmacologic Class

Classes
benzodiazepine [epc] benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687576
Hyphenated Format 60687-576

Supplemental Identifiers

RxCUI
422410
UNII
W7TTW573JJ

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name midazolam hydrochloride (source: ndc)
Generic Name midazolam hydrochloride (source: ndc)
Application Number ANDA075873 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 3 TRAY in 1 CASE (60687-576-10) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-576-04) / 2.5 mL in 1 CUP, UNIT-DOSE (60687-576-03)
  • 3 TRAY in 1 CASE (60687-576-86) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-576-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-576-40)
source: ndc

Packages (2)

60687-576-10 3 TRAY in 1 CASE (60687-576-10) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-576-04) / 2.5 mL in 1 CUP, UNIT-DOSE (60687-576-03) 60687-576-86 3 TRAY in 1 CASE (60687-576-86) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-576-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-576-40)

Ingredients (1)

midazolam hydrochloride (2 mg/mL)

Linked Drug Pages (1)

Midazolam Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "34f38926-e4e4-8bae-e063-6394a90a60ba", "openfda": {"unii": ["W7TTW573JJ"], "rxcui": ["422410"], "spl_set_id": ["fc93242b-0abf-466a-8413-8a365620ee75"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "3 TRAY in 1 CASE (60687-576-10)  / 10 CUP, UNIT-DOSE in 1 TRAY (60687-576-04)  / 2.5 mL in 1 CUP, UNIT-DOSE (60687-576-03)", "package_ndc": "60687-576-10", "marketing_start_date": "20210615"}, {"sample": false, "description": "3 TRAY in 1 CASE (60687-576-86)  / 10 CUP, UNIT-DOSE in 1 TRAY (60687-576-46)  / 5 mL in 1 CUP, UNIT-DOSE (60687-576-40)", "package_ndc": "60687-576-86", "marketing_start_date": "20210615"}], "brand_name": "Midazolam Hydrochloride", "product_id": "60687-576_34f38926-e4e4-8bae-e063-6394a90a60ba", "dosage_form": "SYRUP", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]"], "product_ndc": "60687-576", "dea_schedule": "CIV", "generic_name": "Midazolam Hydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midazolam Hydrochloride", "active_ingredients": [{"name": "MIDAZOLAM HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA075873", "marketing_category": "ANDA", "marketing_start_date": "20210615", "listing_expiration_date": "20261231"}