FDA.reportPublic FDA data

HYDROMORPHONE HYDROCHLORIDE

Product NDC
63629-2532
11-digit product format
636292532
Labeler code
63629
Product ID
63629-2532_971f9f4c-1e16-40fb-b08f-e5dc1424e2d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROMORPHONE HYDROCHLORIDE
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1996-01-31
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
3 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HYDROMORPHONE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROMORPHONE HYDROCHLORIDE3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L960UP2KRWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
897749Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bec32a94-4b79-4bd4-b000-45e9030d3106Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2532-1HYDROMORPHONE HYDROCHLORIDE1 in 1 PACKETSUPPOSITORY1103
63629-2532-1HYDROMORPHONE HYDROCHLORIDE6 in 1 BOXSUPPOSITORY6103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2532-1EA - Each63629-2532f64a0167-efc9-417d-b3ed-7210897b88a812021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2532HYDROMORPHONE HYDROCHLORIDE SUPPOSITORY [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20240112_bec32a94-4b79-4bd4-b000-45e9030d3106.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepackbec32a94-4b79-4bd4-b000-45e9030d31062024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 63629-2532

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897749HYDROmorphone HCl 3 MG Rectal SuppositoryPSNbec32a94-4b79-4bd4-b000-45e9030d3106103
897749hydromorphone hydrochloride 3 MG Rectal SuppositorySCDbec32a94-4b79-4bd4-b000-45e9030d3106103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2532-1636292532016 PACKET in 1 BOX (63629-2532-1) / 1 SUPPOSITORY in 1 PACKET6 packet2021-04-280000-00-00NoNoCurrent