FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
52959-408
11-digit product format
529590408
Labeler code
52959
Product ID
52959-408_0a9c8629-be18-4f5d-8f19-e96b46d63dbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA078439
Marketing category
ANDA
Marketing start
2009-12-09
Marketing end
0000-00-00
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2018-12-31
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
52959-408-022020-01-31C16284748780-19d75b9d0-dc0f-f424-e053-dadaa90a57ceHYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mg
52959-408-302020-01-31C16284748780-19d75b9d0-dc0f-f424-e053-dadaa90a57ceHYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mg
52959-408-602020-01-31C16284748780-19d75b9d0-dc0f-f424-e053-dadaa90a57ceHYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-408-02Hydromorphone Hydrochloride120 in 1 BOTTLE, PLASTICTABLET1202
52959-408-30Hydromorphone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
52959-408-60Hydromorphone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-408-02EA - Each52959-408c6c8ce34-af30-4d3c-bd36-ca14c0bf890212012-07-24
52959-408-30EA - Each52959-408410a5990-faa3-405d-a9a8-ee5382c6c9f212012-07-24
52959-408-60EA - Each52959-40853f0d639-16e7-4f1d-9cb3-a2fa108fb5d812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydromorphone HydrochlorideACTIVE INGREDIENTL960UP2KRWHYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
HydromorphoneACTIVE MOIETYQ812464R06HYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKHYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XHYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30HYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-408HYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 3 package rows20111209_7c122909-cedb-469a-99de-a44bcd51238d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897696HYDROmorphone HCl 2 MG Oral TabletPSN7c122909-cedb-469a-99de-a44bcd51238d2
897702HYDROmorphone HCl 4 MG Oral TabletPSN7c122909-cedb-469a-99de-a44bcd51238d2
897710HYDROmorphone HCl 8 MG Oral TabletPSN7c122909-cedb-469a-99de-a44bcd51238d2
897696hydromorphone hydrochloride 2 MG Oral TabletSCD7c122909-cedb-469a-99de-a44bcd51238d2
897702hydromorphone hydrochloride 4 MG Oral TabletSCD7c122909-cedb-469a-99de-a44bcd51238d2
897710hydromorphone hydrochloride 8 MG Oral TabletSCD7c122909-cedb-469a-99de-a44bcd51238d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-408-0252959040802120 in 1 BOTTLE, PLASTICHistorical
52959-408-305295904083030 in 1 BOTTLE, PLASTICHistorical
52959-408-605295904086060 in 1 BOTTLE, PLASTICHistorical