FDA.reportPublic FDA data

Hydromorphone Hydrochloride

Product NDC
13811-701
11-digit product format
138110701
Labeler code
13811
Product ID
13811-701_e22a1e07-ff84-4ef1-b154-804b49dcd52f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Trigen Laboratories, LLC
Application
ANDA205629
Marketing category
ANDA
Marketing start
2016-09-15
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
8 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 HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL960UP2KRW
Rxcui902729, 902736, 902741, 1306898, 2706360

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
13811-701-10Hydromorphone Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE10029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13811-701-10EA - Each13811-701c3f90f9b-c58c-419c-ad11-fee1d684553e12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13811-701HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [TRIGEN LABORATORIES, LLC]26Current NDC, Legacy NDC, 1 package rows20250302_8bb81796-6990-40e9-bee4-1f292f91ae99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
902729HYDROmorphone HCl 12 MG 24HR Extended Release Oral TabletPSN8bb81796-6990-40e9-bee4-1f292f91ae9929
902736HYDROmorphone HCl 16 MG 24HR Extended Release Oral TabletPSN8bb81796-6990-40e9-bee4-1f292f91ae9929
1306898HYDROmorphone HCl 32 MG 24HR Extended Release Oral TabletPSN8bb81796-6990-40e9-bee4-1f292f91ae9929
902741HYDROmorphone HCl 8 MG 24HR Extended Release Oral TabletPSN8bb81796-6990-40e9-bee4-1f292f91ae9929
2706360HYDROmorphone hydrochloride 24 MG 24HR Extended Release Oral TabletPSN8bb81796-6990-40e9-bee4-1f292f91ae9929
90272924 HR hydromorphone hydrochloride 12 MG Extended Release Oral TabletSCD8bb81796-6990-40e9-bee4-1f292f91ae9929
90273624 HR hydromorphone hydrochloride 16 MG Extended Release Oral TabletSCD8bb81796-6990-40e9-bee4-1f292f91ae9929
270636024 HR hydromorphone hydrochloride 24 MG Extended Release Oral TabletSCD8bb81796-6990-40e9-bee4-1f292f91ae9929
130689824 HR hydromorphone hydrochloride 32 MG Extended Release Oral TabletSCD8bb81796-6990-40e9-bee4-1f292f91ae9929
90274124 HR hydromorphone hydrochloride 8 MG Extended Release Oral TabletSCD8bb81796-6990-40e9-bee4-1f292f91ae9929
2706360hydromorphone HCl 24 MG 24 HR Extended Release Oral TabletSY8bb81796-6990-40e9-bee4-1f292f91ae9929
902729hydromorphone hydrochloride 12 MG 24 HR Extended Release Oral TabletSY8bb81796-6990-40e9-bee4-1f292f91ae9929
902736hydromorphone hydrochloride 16 MG 24 HR Extended Release Oral TabletSY8bb81796-6990-40e9-bee4-1f292f91ae9929
1306898hydromorphone hydrochloride 32 MG 24 HR Extended Release Oral TabletSY8bb81796-6990-40e9-bee4-1f292f91ae9929
902741hydromorphone hydrochloride 8 MG 24 HR Extended Release Oral TabletSY8bb81796-6990-40e9-bee4-1f292f91ae9929

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13811-701-1013811070110100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-701-10) 2016-09-150000-00-00NoNoCurrent