Hydromorphone Hydrochloride

Product NDC
87063-038
11-digit product format
870630038
Labeler code
87063
Product ID
87063-038_451ccd08-4749-97a1-e063-6294a90ac5ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ASCLEMED USA INC.
Application
NDA019892
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-11-23
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019892-001DILAUDIDHYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORALABRLD, RS1992-12-07
N019892-002DILAUDIDHYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORALABRLD2007-11-09
N019892-003DILAUDIDHYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORALABRLD2007-11-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N019892-001AB
N019892-002AB
N019892-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019892-001DILAUDID8MGTABLET / ORALABRLD, RS1992-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019892-002DILAUDID4MGTABLET / ORALABRLD2007-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019892-003DILAUDID2MGTABLET / ORALABRLD2007-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019892-001DILAUDID8MGTABLET / ORALABRLD, RS1992-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019892-002DILAUDID4MGTABLET / ORALABRLD2007-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019892-003DILAUDID2MGTABLET / ORALABRLD2007-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N019892-001DILAUDID8MGTABLET / ORALABRLD, RS1992-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019892-002DILAUDID4MGTABLET / ORALABRLD2007-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019892-003DILAUDID2MGTABLET / ORALABRLD2007-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019892-001DILAUDID8MGTABLET / ORALABRLD, RS1992-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019892-002DILAUDID4MGTABLET / ORALABRLD2007-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019892-003DILAUDID2MGTABLET / ORALABRLD2007-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019892-001DILAUDID8MGTABLET / ORALABRLD, RS1992-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019892-002DILAUDID4MGTABLET / ORALABRLD2007-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019892-003DILAUDID2MGTABLET / ORALABRLD2007-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019892-001DILAUDID8MGTABLET / ORALABRLD, RS1992-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019892-002DILAUDID4MGTABLET / ORALABRLD2007-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019892-003DILAUDID2MGTABLET / ORALABRLD2007-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019892-001DILAUDID8MGTABLET / ORALABRLD, RS1992-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019892-002DILAUDID4MGTABLET / ORALABRLD2007-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019892-003DILAUDID2MGTABLET / ORALABRLD2007-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019892-001DILAUDID8MGTABLET / ORALABRLD, RS1992-12-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019892-002DILAUDID4MGTABLET / ORALABRLD2007-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019892-003DILAUDID2MGTABLET / ORALABRLD2007-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019892-001DILAUDID8MGTABLET / ORALABRLD, RS1992-12-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019892-002DILAUDID4MGTABLET / ORALABRLD2007-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019892-003DILAUDID2MGTABLET / ORALABRLD2007-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019892-001DILAUDID8MGTABLET / ORALABRLD, RS1992-12-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N019892-002DILAUDID4MGTABLET / ORALABRLD2007-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N019892-003DILAUDID2MGTABLET / ORALABRLD2007-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019892-001DILAUDID8MGTABLET / ORALABRLD, RS1992-12-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019892-002DILAUDID4MGTABLET / ORALABRLD2007-11-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019892-003DILAUDID2MGTABLET / ORALABRLD2007-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019892-001DILAUDID8MGTABLET / ORALABRLD, RS1992-12-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019892-002DILAUDID4MGTABLET / ORALABRLD2007-11-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019892-003DILAUDID2MGTABLET / ORALABRLD2007-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019892-001DILAUDID8MGTABLET / ORALABRLD, RS1992-12-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019892-002DILAUDID4MGTABLET / ORALABRLD2007-11-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019892-003DILAUDID2MGTABLET / ORALABRLD2007-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019892-001DILAUDID8MGTABLET / ORALABRLD, RS1992-12-078072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019892-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019892-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019892-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019892-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019892-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019892-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019892-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019892-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019892-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019892-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019892-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019892-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019892-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019892-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019892-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019892-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019892-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019892-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019892-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019892-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019892-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019892-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019892-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019892-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019892-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019892-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019892-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019892-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019892-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019892-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019892-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019892-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019892-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019892-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019892-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019892-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019892-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019892-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019892-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019892-001AB18072bd15b7f6…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N019892-00165899602020-11-09Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019892-00265899602020-11-09Drug substance, Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019892-00365899602020-11-09Drug substance, Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N019892-00165899602020-11-09Drug substance, Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N019892-00265899602020-11-09Drug substance, Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N019892-00365899602020-11-09Drug substance, Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019892-00165899602020-11-09Drug substance, Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N019892-00265899602020-11-09Drug substance, Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N019892-00365899602020-11-09Drug substance, Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N019892-00165899602020-11-09Drug substance, Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N019892-00265899602020-11-09Drug substance, Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N019892-00365899602020-11-09Drug substance, Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N019892-00165899602020-11-09Drug substance, Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N019892-00265899602020-11-09Drug substance, Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N019892-00365899602020-11-09Drug substance, Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N019892-00165899602020-11-09Drug substance, Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N019892-00265899602020-11-09Drug substance, Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N019892-00365899602020-11-09Drug substance, Drug productea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Hydromorphone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROMORPHONE HYDROCHLORIDE4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L960UP2KRWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
897696Internal RxNorm lookup
897702Internal RxNorm lookup
897710Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
18f6f54e-1537-4181-9d07-54ddf881a9eeAvailable on FDA.report

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
87063-038-01Hydromorphone Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1001
87063-038-05Hydromorphone Hydrochloride5 in 1 BOTTLE, PLASTICTABLET51
87063-038-07Hydromorphone Hydrochloride7 in 1 BOTTLE, PLASTICTABLET71
87063-038-10Hydromorphone Hydrochloride10 in 1 BOTTLE, PLASTICTABLET101
87063-038-14Hydromorphone Hydrochloride14 in 1 BOTTLE, PLASTICTABLET141
87063-038-20Hydromorphone Hydrochloride20 in 1 BOTTLE, PLASTICTABLET201
87063-038-30Hydromorphone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET301
87063-038-50Hydromorphone Hydrochloride500 in 1 BOTTLE, PLASTICTABLET5001
87063-038-60Hydromorphone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET601
87063-038-90Hydromorphone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET901

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepack2427814c-f32b-8ac5-99b8-5e886fd2d0012026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019892
application number: NDA019892
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy53ddcacc-99e4-8b21-e063-6394a90a3e792026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019892
application number: NDA019892
DilaudidHYDROMORPHONE HYDROCHLORIDERhodes Pharmaceuticals LLCd6b40e39-a57e-402c-b4f6-7041e832f8372026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019892
application number: NDA019892
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDERhodes Pharmaceuticals LLC37565441-0d95-4743-a695-d7b3326f58a12026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019892
application number: NDA019892
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEBryant Ranch Prepackc48e2e9a-cb5b-46b8-b6be-3dd76e80d0ca2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019892
application number: NDA019892
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEASCLEMED USA INC.18f6f54e-1537-4181-9d07-54ddf881a9ee2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019892
application number: NDA019892
ndc (product): 87063-038

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897696HYDROmorphone HCl 2 MG Oral TabletPSN18f6f54e-1537-4181-9d07-54ddf881a9ee1
897702HYDROmorphone HCl 4 MG Oral TabletPSN18f6f54e-1537-4181-9d07-54ddf881a9ee1
897710HYDROmorphone HCl 8 MG Oral TabletPSN18f6f54e-1537-4181-9d07-54ddf881a9ee1
897696hydromorphone hydrochloride 2 MG Oral TabletSCD18f6f54e-1537-4181-9d07-54ddf881a9ee1
897702hydromorphone hydrochloride 4 MG Oral TabletSCD18f6f54e-1537-4181-9d07-54ddf881a9ee1
897710hydromorphone hydrochloride 8 MG Oral TabletSCD18f6f54e-1537-4181-9d07-54ddf881a9ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87063-038-0187063003801100 TABLET in 1 BOTTLE, PLASTIC (87063-038-01) 100 tablet2025-12-04NoNoCurrent
87063-038-05870630038055 TABLET in 1 BOTTLE, PLASTIC (87063-038-05) 5 tablet2025-12-04NoNoCurrent
87063-038-07870630038077 TABLET in 1 BOTTLE, PLASTIC (87063-038-07) 7 tablet2025-12-04NoNoCurrent
87063-038-108706300381010 TABLET in 1 BOTTLE, PLASTIC (87063-038-10) 10 tablet2025-12-04NoNoCurrent
87063-038-148706300381414 TABLET in 1 BOTTLE, PLASTIC (87063-038-14) 14 tablet2025-12-04NoNoCurrent
87063-038-208706300382020 TABLET in 1 BOTTLE, PLASTIC (87063-038-20) 20 tablet2025-12-04NoNoCurrent
87063-038-308706300383030 TABLET in 1 BOTTLE, PLASTIC (87063-038-30) 30 tablet2025-12-04NoNoCurrent
87063-038-5087063003850500 TABLET in 1 BOTTLE, PLASTIC (87063-038-50) 500 tablet2025-12-03NoNoCurrent
87063-038-608706300386060 TABLET in 1 BOTTLE, PLASTIC (87063-038-60) 60 tablet2025-12-04NoNoCurrent
87063-038-908706300389090 TABLET in 1 BOTTLE, PLASTIC (87063-038-90) 90 tablet2025-12-04NoNoCurrent