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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076855-001 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | AB | 2004-12-23 | |
| A076855-002 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | AB | 2007-09-19 | |
| A076855-003 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | AB | 2007-09-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076855-001 | AB |
| A076855-002 | AB |
| A076855-003 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076855-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | AB | 2004-12-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076855-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | AB | 2007-09-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076855-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | AB | 2007-09-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076855-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | AB | 2004-12-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076855-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | AB | 2007-09-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076855-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | AB | 2007-09-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076855-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | AB | 2004-12-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076855-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | AB | 2007-09-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076855-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | AB | 2007-09-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076855-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | AB | 2004-12-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076855-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | AB | 2007-09-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076855-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | AB | 2007-09-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076855-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | AB | 2004-12-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076855-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | AB | 2007-09-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076855-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | AB | 2007-09-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076855-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | AB | 2004-12-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076855-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | AB | 2007-09-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076855-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | AB | 2007-09-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076855-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | AB | 2004-12-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076855-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | AB | 2007-09-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076855-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | AB | 2007-09-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076855-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | AB | 2004-12-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076855-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | AB | 2007-09-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076855-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | AB | 2007-09-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076855-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | AB | 2004-12-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076855-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | AB | 2007-09-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076855-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | AB | 2007-09-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076855-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | AB | 2004-12-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076855-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | AB | 2007-09-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076855-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | AB | 2007-09-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076855-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | AB | 2004-12-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076855-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | AB | 2007-09-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076855-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | AB | 2007-09-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076855-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | AB | 2004-12-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076855-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | AB | 2007-09-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076855-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | AB | 2007-09-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076855-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | AB | 2004-12-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076855-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | AB | 2007-09-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076855-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | AB | 2007-09-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076855-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | AB | 2004-12-23 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076855-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076855-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076855-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076855-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076855-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076855-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076855-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076855-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076855-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076855-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076855-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076855-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076855-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076855-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076855-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076855-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076855-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076855-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076855-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076855-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076855-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076855-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076855-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076855-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076855-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076855-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076855-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076855-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076855-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076855-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076855-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076855-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076855-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076855-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076855-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076855-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076855-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076855-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076855-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076855-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydromorphone Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROMORPHONE HYDROCHLORIDE | 8 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L960UP2KRW | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4c5c1cc8-c42b-46e3-ad68-8e22f57101f2 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c92985da-a658-b186-e763-2287eda87a86 | Product name | 3 | 20250221 |
| 96c475b3-58c7-b955-d715-0111804a3e50 | Product name | 5 | 20210512 |
| 1dd54659-b775-4fa8-a858-7f0e521fbadc | Product name | 4 | 20200925 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0406-3249-01 | Hydromorphone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 28 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0406-3249-01 | EA - Each | 0406-3249 | 68117032-8508-4570-802e-bc80ecf8be78 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | SpecGx LLC | 4c5c1cc8-c42b-46e3-ad68-8e22f57101f2 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 076855 ANDA076855 0406-3249 |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | American Health Packaging | e4758743-9b2c-4612-8399-ad2db372e2b7 | 2026-02-27 | Boxed warning, Warnings, Adverse reactions | 076855 ANDA076855 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 897696 | HYDROmorphone HCl 2 MG Oral Tablet | PSN | 4c5c1cc8-c42b-46e3-ad68-8e22f57101f2 | 28 |
| 897702 | HYDROmorphone HCl 4 MG Oral Tablet | PSN | 4c5c1cc8-c42b-46e3-ad68-8e22f57101f2 | 28 |
| 897710 | HYDROmorphone HCl 8 MG Oral Tablet | PSN | 4c5c1cc8-c42b-46e3-ad68-8e22f57101f2 | 28 |
| 897696 | hydromorphone hydrochloride 2 MG Oral Tablet | SCD | 4c5c1cc8-c42b-46e3-ad68-8e22f57101f2 | 28 |
| 897702 | hydromorphone hydrochloride 4 MG Oral Tablet | SCD | 4c5c1cc8-c42b-46e3-ad68-8e22f57101f2 | 28 |
| 897710 | hydromorphone hydrochloride 8 MG Oral Tablet | SCD | 4c5c1cc8-c42b-46e3-ad68-8e22f57101f2 | 28 |
| 897696 | HYDROmorphone HCl 2 MG Oral Tablet | PSN | 2115e839-c64f-4a6f-9001-bf91ddd89630 | 1 |
| 897702 | HYDROmorphone HCl 4 MG Oral Tablet | PSN | 2115e839-c64f-4a6f-9001-bf91ddd89630 | 1 |
| 897710 | HYDROmorphone HCl 8 MG Oral Tablet | PSN | 2115e839-c64f-4a6f-9001-bf91ddd89630 | 1 |
| 897696 | hydromorphone hydrochloride 2 MG Oral Tablet | SCD | 2115e839-c64f-4a6f-9001-bf91ddd89630 | 1 |
| 897702 | hydromorphone hydrochloride 4 MG Oral Tablet | SCD | 2115e839-c64f-4a6f-9001-bf91ddd89630 | 1 |
| 897710 | hydromorphone hydrochloride 8 MG Oral Tablet | SCD | 2115e839-c64f-4a6f-9001-bf91ddd89630 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0406-3249-01 | 00406324901 | 100 TABLET in 1 BOTTLE (0406-3249-01) | 100 tablet | 2004-12-23 | 0000-00-00 | No | No | Current |