Dilaudid

Product NDC
42858-122
11-digit product format
428580122
Labeler code
42858
Product ID
42858-122_3348b431-907c-4f1d-8a18-e4be2a04df23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydromorphone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rhodes Pharmaceuticals LLC
Application
NDA019892
Marketing category
NDA
Marketing start
2017-05-15
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
2 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

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
Dilaudid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROMORPHONE HYDROCHLORIDE2 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 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
897657Internal RxNorm lookup
897658Internal RxNorm lookup
897696Internal RxNorm lookup
897698Internal RxNorm lookup
897702Internal RxNorm lookup
897704Internal RxNorm lookup
897710Internal RxNorm lookup
897712Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d6b40e39-a57e-402c-b4f6-7041e832f837Available 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
42858-122-01Dilaudid100 in 1 BOTTLE, PLASTICTABLET10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42858-122-01EA - Each42858-1222591eb5c-5193-42fb-84de-4108eb217e7012017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42858-122DILAUDID (HYDROMORPHONE HYDROCHLORIDE) TABLET DILAUDID (HYDROMORPHONE HYDROCHLORIDE) SOLUTION [RHODES PHARMACEUTICALS L.P.]9Current NDC, Legacy NDC, 1 package rows20240110_d6b40e39-a57e-402c-b4f6-7041e832f837.zip

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
ndc (product): 42858-122
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897658Dilaudid 1 MG in 1 mL Oral SolutionPSNd6b40e39-a57e-402c-b4f6-7041e832f83712
897698DILAUDID 2 MG Oral TabletPSNd6b40e39-a57e-402c-b4f6-7041e832f83712
897704DILAUDID 4 MG Oral TabletPSNd6b40e39-a57e-402c-b4f6-7041e832f83712
897712DILAUDID 8 MG Oral TabletPSNd6b40e39-a57e-402c-b4f6-7041e832f83712
897657HYDROmorphone HCl 1 MG in 1 mL Oral SolutionPSNd6b40e39-a57e-402c-b4f6-7041e832f83712
897696HYDROmorphone HCl 2 MG Oral TabletPSNd6b40e39-a57e-402c-b4f6-7041e832f83712
897702HYDROmorphone HCl 4 MG Oral TabletPSNd6b40e39-a57e-402c-b4f6-7041e832f83712
897710HYDROmorphone HCl 8 MG Oral TabletPSNd6b40e39-a57e-402c-b4f6-7041e832f83712
897658hydromorphone hydrochloride 1 MG/ML Oral Solution [Dilaudid]SBDd6b40e39-a57e-402c-b4f6-7041e832f83712
897698hydromorphone hydrochloride 2 MG Oral Tablet [Dilaudid]SBDd6b40e39-a57e-402c-b4f6-7041e832f83712
897704hydromorphone hydrochloride 4 MG Oral Tablet [Dilaudid]SBDd6b40e39-a57e-402c-b4f6-7041e832f83712
897712hydromorphone hydrochloride 8 MG Oral Tablet [Dilaudid]SBDd6b40e39-a57e-402c-b4f6-7041e832f83712
897657hydromorphone hydrochloride 1 MG/ML Oral SolutionSCDd6b40e39-a57e-402c-b4f6-7041e832f83712
897696hydromorphone hydrochloride 2 MG Oral TabletSCDd6b40e39-a57e-402c-b4f6-7041e832f83712
897702hydromorphone hydrochloride 4 MG Oral TabletSCDd6b40e39-a57e-402c-b4f6-7041e832f83712
897710hydromorphone hydrochloride 8 MG Oral TabletSCDd6b40e39-a57e-402c-b4f6-7041e832f83712
897658Dilaudid 1 MG per 1 ML Oral SolutionSYd6b40e39-a57e-402c-b4f6-7041e832f83712
897658Dilaudid 1 MG/ML Oral SolutionSYd6b40e39-a57e-402c-b4f6-7041e832f83712
897698Dilaudid 2 MG Oral TabletSYd6b40e39-a57e-402c-b4f6-7041e832f83712
897704Dilaudid 4 MG Oral TabletSYd6b40e39-a57e-402c-b4f6-7041e832f83712
897712Dilaudid 8 MG Oral TabletSYd6b40e39-a57e-402c-b4f6-7041e832f83712
897657hydromorphone HCl 1 MG per 1 ML Oral SolutionSYd6b40e39-a57e-402c-b4f6-7041e832f83712
897657hydromorphone HCl 5 MG per 5 ML Oral SolutionSYd6b40e39-a57e-402c-b4f6-7041e832f83712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42858-122-0142858012201100 TABLET in 1 BOTTLE, PLASTIC (42858-122-01) 100 tablet2017-05-150000-00-00NoNoCurrent
42858-122-25428580122254 BLISTER PACK in 1 CARTON (42858-122-25) > 25 TABLET in 1 BLISTER PACK4 blister pack2017-05-150000-00-00NoNoCurrent