FDA.reportPublic FDA data

Application 078439

Type
ANDA
Sponsor
LANNETT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDETABLET;ORAL2MGNoNo
002HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDETABLET;ORAL4MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDESpecGx LLC4c5c1cc8-c42b-46e3-ad68-8e22f57101f22026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepack2427814c-f32b-8ac5-99b8-5e886fd2d0012026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy53ddcacc-99e4-8b21-e063-6394a90a3e792026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
DilaudidHYDROMORPHONE HYDROCHLORIDERhodes Pharmaceuticals LLCd6b40e39-a57e-402c-b4f6-7041e832f8372026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETeva Parenteral Medicines, Inc.f0b78db9-a38c-41bb-8233-5e93f7f18c5c2026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDERhodes Pharmaceuticals LLC37565441-0d95-4743-a695-d7b3326f58a12026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEAmerican Health Packagingfab97112-e276-40e0-bc82-0a29d7fa75fa2026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.3832ede8-d3fc-455d-ecab-3b77be5869f52026-04-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepackc48e2e9a-cb5b-46b8-b6be-3dd76e80d0ca2026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b325028e-0722-4c8c-9fdb-ab6fb0dc460c2026-03-02Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEAmerican Health Packaginge4758743-9b2c-4612-8399-ad2db372e2b72026-02-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.cc574063-6ede-4da7-82c4-7450c92b229b2026-02-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.f9ca2ef5-46d8-475a-a26e-f7c8becd6db72026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEHospira, Inc.e9c9ef18-7dfc-4322-b2fc-29b934c30f8b2025-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETrigen Laboratories, LLC8bb81796-6990-40e9-bee4-1f292f91ae992025-12-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochlorideHYDROMORPHONE HYDROCHLORIDEPadagis US LLC780a2616-0392-4715-bc50-71799bea19572025-12-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: hydromorphone hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEASCLEMED USA INC.18f6f54e-1537-4181-9d07-54ddf881a9ee2025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochlorideHYDROMORPHONE HYDROCHLORIDECamber Pharmaceuticals, Inc.c33e6320-4206-4b69-8cac-ebfc2351b8f22025-08-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: hydromorphone hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE
DilaudidHYDROMORPHONE HYDROCHLORIDEFresenius Kabi USA, LLC9eebd88a-5632-460f-b7b6-26c8a180540d2025-04-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: HYDROMORPHONE HYDROCHLORIDE
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEFresenius Kabi USA, LLCe034eb96-03e0-46e1-8b92-5e1f94555e7b2025-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Hydromorphone Hydrochloride
generic name: HYDROMORPHONE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35356-815Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-815Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-815Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-815Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-816Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-816Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-816Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-816Hydromorphone HydrochlorideHydromorphone HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
52959-408Hydromorphone HydrochlorideHydromorphone HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
52959-420Hydromorphone HydrochlorideHydromorphone HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
68084-423Hydromorphone HydrochlorideHydromorphone HydrochlorideAmerican Health PackagingANDACurrent
68084-472Hydromorphone HydrochlorideHydromorphone HydrochlorideAmerican Health PackagingANDACurrent