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Hydromorphone Hydrochloride

These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION and HYDROMORPHONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION and HYDROMORPHONE HYDROCHLORIDE TABLETS. Hydromorphone hydrochloride oral solution Hydromorphone hydrochloride tablets, for oral use, CII Initial U.S. Approval: January 1984

Approved
Approval ID

37565441-0d95-4743-a695-d7b3326f58a1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 17, 2024

Manufacturers
FDA

Rhodes Pharmaceuticals L.P.

DUNS: 831928986

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hydromorphone Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42858-304
Application NumberNDA019891
Product Classification
M
Marketing Category
C73605
G
Generic Name
Hydromorphone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2023
FDA Product Classification

INGREDIENTS (7)

HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 5 mg in 5 mL
Code: L960UP2KRW
Classification: ACTIB
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT

Hydromorphone Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42858-303
Application NumberNDA019892
Product Classification
M
Marketing Category
C73605
G
Generic Name
Hydromorphone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2023
FDA Product Classification

INGREDIENTS (4)

HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 8 mg in 1 1
Code: L960UP2KRW
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT

Hydromorphone Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42858-302
Application NumberNDA019892
Product Classification
M
Marketing Category
C73605
G
Generic Name
Hydromorphone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2023
FDA Product Classification

INGREDIENTS (5)

D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 4 mg in 1 1
Code: L960UP2KRW
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT

Hydromorphone Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42858-301
Application NumberNDA019892
Product Classification
M
Marketing Category
C73605
G
Generic Name
Hydromorphone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2023
FDA Product Classification

INGREDIENTS (6)

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 2 mg in 1 1
Code: L960UP2KRW
Classification: ACTIB
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT

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Hydromorphone Hydrochloride - FDA Drug Approval Details