FDA.reportPublic FDA data

Midazolam Hydrochloride

Product NDC
60687-576
Requested package NDC
60687-576-86
11-digit product format
606870576
Labeler code
60687
Product ID
60687-576_34f38926-e4e4-8bae-e063-6394a90a60ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Midazolam Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
American Health Packaging
Application
ANDA075873
Marketing category
ANDA
Marketing start
2021-06-15
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075873-001MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEEQ 2MG BASE/MLSYRUP / ORALAARS2002-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A075873-001AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075873-001MIDAZOLAM HYDROCHLORIDEEQ 2MG BASE/MLSYRUP / ORALAARS2002-04-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075873-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEAmerican Health Packagingfc93242b-0abf-466a-8413-8a365620ee752026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075873
application number: ANDA075873
ndc (package): 60687-576-86
ndc (product): 60687-576
ndc11 (package): 60687057686
Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEPrecision Dose Inc.9a443652-6aff-4e27-83fe-90c65fa0f3c12026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075873
application number: ANDA075873
Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEPrecision Dose Inc.557ef7bf-9341-47f9-804d-430a24982fa62025-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075873
application number: ANDA075873
Midazolam HydrochlorideMIDAZOLAM HYDROCHLORIDEHikma Pharmaceuticals USA Inc.a833c24b-6dca-44d7-a0d6-20012fa1ea772025-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075873
application number: ANDA075873

Additional Listing Data#

Finished product
Yes
Brand name base
Midazolam Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIDAZOLAM HYDROCHLORIDE2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W7TTW573JJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
422410Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fc93242b-0abf-466a-8413-8a365620ee75Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1d526338-43ba-4cef-8730-5a757122f8ceProduct name120260218
8118475d-d61b-4326-b353-56e9cf8c8d9fProduct name320260218
f69f3735-bf62-03e6-cc7a-5af4af89ec8aProduct name520250516
4cc03496-da49-494d-b71d-757fe6737fa2Product name120230717
06641162-4d53-492d-8ff2-5951a469060fProduct name120230420
46ca420c-e4d5-4e6c-9b2f-cea269a262e8Product name120230320
b84efe2b-3f4e-4b09-90f9-1d24a61ec30eProduct name120190808
bb7f99f4-8b2b-42a4-8f5a-fcf7dc204f16Product name120181220
31f18c4e-1938-700a-43de-b9e218c36edcProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-576-03Midazolam Hydrochloride2.5 mL in 1 CUP, UNIT-DOSESYRUP2.54
60687-576-04Midazolam Hydrochloride10 in 1 TRAYSYRUP104
60687-576-10Midazolam Hydrochloride3 in 1 CASESYRUP34
60687-576-40Midazolam Hydrochloride5 mL in 1 CUP, UNIT-DOSESYRUP54
60687-576-46Midazolam Hydrochloride10 in 1 TRAYSYRUP104
60687-576-86Midazolam Hydrochloride3 in 1 CASESYRUP34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-576-03ML - Milliliter60687-57619b9aac4-b9ad-4025-8426-02a466fcae8712021-06-02
60687-576-04ML - Milliliter60687-5765e70e6f4-498f-4f52-8520-c59b6e0d420e12021-07-15
60687-576-10ML - Milliliter60687-5769c4a46b0-1b7d-493d-9418-d1ca29f7c47112021-06-02
60687-576-40ML - Milliliter60687-576dd2b08e4-5041-431b-9949-5e91514b380912021-06-02
60687-576-46ML - Milliliter60687-576a6558fa5-5b77-4c0f-8528-d00b1a1cb1aa12021-07-15
60687-576-86ML - Milliliter60687-576c28e926a-e207-4057-9264-80f54b96b4b212021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-576MIDAZOLAM HYDROCHLORIDE SYRUP [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 6 package rows20250514_fc93242b-0abf-466a-8413-8a365620ee75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
422410midazolam 10 MG in 5 mL Oral SolutionPSNfc93242b-0abf-466a-8413-8a365620ee754
422410midazolam 2 MG/ML Oral SolutionSCDfc93242b-0abf-466a-8413-8a365620ee754
422410midazolam (as midazolam hydrochloride) 10 MG per 5 ML SyrupSYfc93242b-0abf-466a-8413-8a365620ee754
422410midazolam (as midazolam hydrochloride) 2 MG/ML SyrupSYfc93242b-0abf-466a-8413-8a365620ee754
422410midazolam 10 MG per 5 ML Oral SolutionSYfc93242b-0abf-466a-8413-8a365620ee754

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-576-86606870576863 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) 3 tray2021-06-150000-00-00NoNoCurrent