FDA.reportPublic FDA data

hydromorphone hydrochloride

Product NDC
72865-169
11-digit product format
728650169
Labeler code
72865
Product ID
72865-169_55fb6272-5677-43cf-b92d-5a6a6f484b6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydromorphone hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA212133
Marketing category
ANDA
Marketing start
2020-09-24
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
12 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 HYDROCHLORIDE12 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL960UP2KRW
Rxcui902729, 902736, 902741, 1306898

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
72865-169-01hydromorphone hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-169-01EA - Each72865-169b0c1f908-04a2-4800-b7fe-213704dc86e812021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-169HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [XLCARE PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 1 package rows20240418_90bda45c-9dbe-4ed5-91d0-df8446ad7026.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
902729HYDROmorphone HCl 12 MG 24HR Extended Release Oral TabletPSN90bda45c-9dbe-4ed5-91d0-df8446ad70263
902736HYDROmorphone HCl 16 MG 24HR Extended Release Oral TabletPSN90bda45c-9dbe-4ed5-91d0-df8446ad70263
1306898HYDROmorphone HCl 32 MG 24HR Extended Release Oral TabletPSN90bda45c-9dbe-4ed5-91d0-df8446ad70263
902741HYDROmorphone HCl 8 MG 24HR Extended Release Oral TabletPSN90bda45c-9dbe-4ed5-91d0-df8446ad70263
90272924 HR hydromorphone hydrochloride 12 MG Extended Release Oral TabletSCD90bda45c-9dbe-4ed5-91d0-df8446ad70263
90273624 HR hydromorphone hydrochloride 16 MG Extended Release Oral TabletSCD90bda45c-9dbe-4ed5-91d0-df8446ad70263
130689824 HR hydromorphone hydrochloride 32 MG Extended Release Oral TabletSCD90bda45c-9dbe-4ed5-91d0-df8446ad70263
90274124 HR hydromorphone hydrochloride 8 MG Extended Release Oral TabletSCD90bda45c-9dbe-4ed5-91d0-df8446ad70263
902729hydromorphone hydrochloride 12 MG 24 HR Extended Release Oral TabletSY90bda45c-9dbe-4ed5-91d0-df8446ad70263
902736hydromorphone hydrochloride 16 MG 24 HR Extended Release Oral TabletSY90bda45c-9dbe-4ed5-91d0-df8446ad70263
1306898hydromorphone hydrochloride 32 MG 24 HR Extended Release Oral TabletSY90bda45c-9dbe-4ed5-91d0-df8446ad70263
902741hydromorphone hydrochloride 8 MG 24 HR Extended Release Oral TabletSY90bda45c-9dbe-4ed5-91d0-df8446ad70263

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72865-169-0172865016901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72865-169-01) 2020-09-240000-00-00NoNoCurrent