FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
70166-250
11-digit product format
701660250
Labeler code
70166
Product ID
70166-250_9239d936-4710-79b2-e053-2995a90aae11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydromorphone hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Lohxa
Application
ANDA074653
Marketing category
ANDA
Marketing start
2012-03-01
Marketing end
0000-00-00
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c92985da-a658-b186-e763-2287eda87a86Product name320250221
96c475b3-58c7-b955-d715-0111804a3e50Product name520210512
1dd54659-b775-4fa8-a858-7f0e521fbadcProduct name420200925

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70166-250-032023-01-30C16284748780-1f386c649-ddd4-0266-e053-dadaa90a7c1aHydromorphone Hydrochloride Oral Solution, USP CII
70166-250-042023-01-30C16284748780-1f386c649-ddd4-0266-e053-dadaa90a7c1aHydromorphone Hydrochloride Oral Solution, USP CII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70166-250-03Hydromorphone Hydrochloride1 in 1 BAGSOLUTION12
70166-250-03Hydromorphone Hydrochloride30 in 1 BOXSOLUTION302
70166-250-04Hydromorphone Hydrochloride4 mL in 1 CUP, UNIT-DOSESOLUTION42
70166-250-04Hydromorphone Hydrochloride30 in 1 BOXSOLUTION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70166-250-03ML - Milliliter70166-25089d95963-17bf-4350-a60d-017d03c0c22212024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70166-250HYDROMORPHONE HYDROCHLORIDE SOLUTION [LOHXA]2Legacy NDC, 4 package rows20190911_65c27d6d-43ab-22ce-e053-2991aa0a5164.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897657HYDROmorphone HCl 1 MG in 1 mL Oral SolutionPSN65c27d6d-43ab-22ce-e053-2991aa0a51642
897657hydromorphone hydrochloride 1 MG/ML Oral SolutionSCD65c27d6d-43ab-22ce-e053-2991aa0a51642
897657hydromorphone HCl 1 MG per 1 ML Oral SolutionSY65c27d6d-43ab-22ce-e053-2991aa0a51642
897657hydromorphone HCl 5 MG per 5 ML Oral SolutionSY65c27d6d-43ab-22ce-e053-2991aa0a51642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70166-250-037016602500330 BAG in 1 BOX (70166-250-03) > 1 SYRINGE in 1 BAG > 1 mL in 1 SYRINGE30 bag2018-02-210000-00-00NoNoCurrent
70166-250-047016602500430 CUP, UNIT-DOSE in 1 BOX (70166-250-04) > 4 mL in 1 CUP, UNIT-DOSE2019-05-040000-00-00NoNoCurrent