Hydromorphone Hydrochloride

Product NDC
60687-590
11-digit product format
606870590
Labeler code
60687
Product ID
60687-590_4bd4edc0-b58e-cd45-e063-6294a90a779c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydromorphone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA076855
Marketing category
ANDA
Marketing start
2021-05-11
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydromorphone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROMORPHONE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL960UP2KRW
Rxcui897696, 897702

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
60687-590-01Hydromorphone Hydrochloride100 in 1 BOX, UNIT-DOSETABLET1006
60687-590-11Hydromorphone Hydrochloride1 in 1 BLISTER PACKTABLET16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-590-01EA - Each60687-590d6258ccc-a1cf-44fc-ab39-6f15db7807ca12021-06-02
60687-590-11EA - Each60687-59072b21fcd-91f8-4aee-92bd-422846b488d812021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-590HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20250331_e4758743-9b2c-4612-8399-ad2db372e2b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897696HYDROmorphone HCl 2 MG Oral TabletPSNe4758743-9b2c-4612-8399-ad2db372e2b76
897702HYDROmorphone HCl 4 MG Oral TabletPSNe4758743-9b2c-4612-8399-ad2db372e2b76
897696hydromorphone hydrochloride 2 MG Oral TabletSCDe4758743-9b2c-4612-8399-ad2db372e2b76
897702hydromorphone hydrochloride 4 MG Oral TabletSCDe4758743-9b2c-4612-8399-ad2db372e2b76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-590-0160687059001100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-590-01) / 1 TABLET in 1 BLISTER PACK (60687-590-11) 100 blister pack2021-05-110000-00-00NoNoCurrent
60687-590-11606870590111 in 1 BLISTER PACKHistorical