Hydromorphone Hydrochloride

Product NDC
0406-3249
11-digit product format
004063249
Labeler code
0406
Product ID
0406-3249_8c16f6cf-c3d2-458c-9cd1-4fddd7c473a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydromorphone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA076855
Marketing category
ANDA
Marketing start
2004-12-23
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
8 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
A076855-001HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORALAB2004-12-23
A076855-002HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORALAB2007-09-19
A076855-003HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORALAB2007-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076855-001AB
A076855-002AB
A076855-003AB

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 UTC2026-02A076855-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORALAB2004-12-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076855-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORALAB2007-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076855-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORALAB2007-09-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076855-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORALAB2004-12-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076855-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORALAB2007-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076855-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORALAB2007-09-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076855-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORALAB2004-12-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076855-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORALAB2007-09-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076855-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORALAB2007-09-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076855-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORALAB2004-12-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076855-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORALAB2007-09-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076855-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORALAB2007-09-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076855-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORALAB2004-12-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076855-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORALAB2007-09-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076855-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORALAB2007-09-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076855-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORALAB2004-12-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076855-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORALAB2007-09-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076855-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORALAB2007-09-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076855-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORALAB2004-12-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076855-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORALAB2007-09-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076855-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORALAB2007-09-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076855-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORALAB2004-12-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076855-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORALAB2007-09-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076855-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORALAB2007-09-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076855-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORALAB2004-12-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076855-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORALAB2007-09-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076855-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORALAB2007-09-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076855-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORALAB2004-12-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A076855-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORALAB2007-09-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A076855-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORALAB2007-09-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076855-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORALAB2004-12-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076855-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORALAB2007-09-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076855-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORALAB2007-09-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076855-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORALAB2004-12-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076855-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORALAB2007-09-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076855-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORALAB2007-09-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076855-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORALAB2004-12-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076855-002HYDROMORPHONE HYDROCHLORIDE2MGTABLET / ORALAB2007-09-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076855-003HYDROMORPHONE HYDROCHLORIDE4MGTABLET / ORALAB2007-09-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076855-001HYDROMORPHONE HYDROCHLORIDE8MGTABLET / ORALAB2004-12-238072bd15b7f6…

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 UTC2026-02A076855-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076855-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076855-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076855-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076855-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076855-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076855-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076855-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076855-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076855-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076855-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076855-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076855-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076855-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076855-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076855-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076855-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076855-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076855-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076855-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076855-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076855-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076855-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076855-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076855-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076855-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076855-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076855-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076855-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076855-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076855-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076855-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076855-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076855-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076855-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076855-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076855-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076855-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076855-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076855-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROMORPHONE HYDROCHLORIDE8 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
4c5c1cc8-c42b-46e3-ad68-8e22f57101f2Available 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
0406-3249-01Hydromorphone Hydrochloride100 in 1 BOTTLETABLET10028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-3249-01EA - Each0406-324968117032-8508-4570-802e-bc80ecf8be7812012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-3249HYDROMORPHONE HYDROCHLORIDE TABLET [SPECGX LLC]28Current NDC, Legacy NDC, 1 package rows20250412_4c5c1cc8-c42b-46e3-ad68-8e22f57101f2.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 · 2 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 reactionsExact identifier
application applno (ANDA): 076855
application number: ANDA076855
ndc (product): 0406-3249
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDEAmerican Health Packaginge4758743-9b2c-4612-8399-ad2db372e2b72026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076855
application number: ANDA076855

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897696HYDROmorphone HCl 2 MG Oral TabletPSN4c5c1cc8-c42b-46e3-ad68-8e22f57101f228
897702HYDROmorphone HCl 4 MG Oral TabletPSN4c5c1cc8-c42b-46e3-ad68-8e22f57101f228
897710HYDROmorphone HCl 8 MG Oral TabletPSN4c5c1cc8-c42b-46e3-ad68-8e22f57101f228
897696hydromorphone hydrochloride 2 MG Oral TabletSCD4c5c1cc8-c42b-46e3-ad68-8e22f57101f228
897702hydromorphone hydrochloride 4 MG Oral TabletSCD4c5c1cc8-c42b-46e3-ad68-8e22f57101f228
897710hydromorphone hydrochloride 8 MG Oral TabletSCD4c5c1cc8-c42b-46e3-ad68-8e22f57101f228
897696HYDROmorphone HCl 2 MG Oral TabletPSN2115e839-c64f-4a6f-9001-bf91ddd896301
897702HYDROmorphone HCl 4 MG Oral TabletPSN2115e839-c64f-4a6f-9001-bf91ddd896301
897710HYDROmorphone HCl 8 MG Oral TabletPSN2115e839-c64f-4a6f-9001-bf91ddd896301
897696hydromorphone hydrochloride 2 MG Oral TabletSCD2115e839-c64f-4a6f-9001-bf91ddd896301
897702hydromorphone hydrochloride 4 MG Oral TabletSCD2115e839-c64f-4a6f-9001-bf91ddd896301
897710hydromorphone hydrochloride 8 MG Oral TabletSCD2115e839-c64f-4a6f-9001-bf91ddd896301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-3249-0100406324901100 TABLET in 1 BOTTLE (0406-3249-01) 100 tablet2004-12-230000-00-00NoNoCurrent