Hydromorphone Hydrochloride
- Product NDC
- 0409-1312
- 11-digit product format
- 004091312
- Labeler code
- 0409
- Product ID
- 0409-1312_766e302a-2d03-4d93-b237-2348b57ee517
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROMORPHONE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hospira, Inc.
- Application
- NDA200403
- Marketing category
- NDA
- Marketing start
- 2021-02-01
- Substance
- HYDROMORPHONE HYDROCHLORIDE
- Active strength
- 2 mg/mL
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydromorphone Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROMORPHONE HYDROCHLORIDE | 2 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | L960UP2KRW |
| Rxcui | 897756, 897757, 1433251, 1724383, 1724644, 2675350 |
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 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 597b1cfd-7b31-5048-62be-ca5cd740da2f | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0409-1312-03 | Hydromorphone Hydrochloride | 1 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1 | 33 | |
| 0409-1312-30 | Hydromorphone Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | 33 | |
| 0409-1312-16 | Hydromorphone Hydrochloride | 1 mL in 1 SYRINGE | INJECTION, SOLUTION | 1 | 12 | |
| 0409-1312-36 | Hydromorphone Hydrochloride | 10 in 1 CELLO PACK | INJECTION, SOLUTION | 10 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0409-1312-03 | ML - Milliliter | 0409-1312 | 2aba610f-f975-441e-828b-dcc5506a3d3a | 1 | 2017-04-05 |
| 0409-1312-09 | ML - Milliliter | 0409-1312 | 7759126f-d23b-42fe-85e2-4236c0ad06b2 | 1 | 2017-07-07 |
| 0409-1312-10 | ML - Milliliter | 0409-1312 | 8d33a65e-fedc-472e-aa28-7fe41667be08 | 1 | 2012-07-24 |
| 0409-1312-16 | ML - Milliliter | 0409-1312 | 499deb74-6da5-410b-a9dd-300723eb2a2a | 1 | 2021-03-02 |
| 0409-1312-30 | ML - Milliliter | 0409-1312 | 5d73a474-3839-4d44-b337-3c5570def18a | 1 | 2012-07-24 |
| 0409-1312-36 | ML - Milliliter | 0409-1312 | 1e8b724f-6f88-4354-8a85-d16b4197bb46 | 1 | 2021-03-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| HYDROMORPHONE HYDROCHLORIDE | ACTIVE INGREDIENT | L960UP2KRW | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| HYDROMORPHONE | ACTIVE MOIETY | Q812464R06 | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| LACTIC ACID, UNSPECIFIED FORM | INACTIVE INGREDIENT | 33X04XA5AT | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| SODIUM LACTATE | INACTIVE INGREDIENT | TU7HW0W0QT | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0409-1312 | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 30 | Current NDC, Legacy NDC, 2 package rows | 20241206_e9c9ef18-7dfc-4322-b2fc-29b934c30f8b.zip |
| 0409-1312 | HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240517_f9ca2ef5-46d8-475a-a26e-f7c8becd6db7.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1724383 | HYDROmorphone HCl 1 MG in 1 ML Cartridge | PSN | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897653 | HYDROmorphone HCl 1 MG in 1 ML Injection | PSN | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897756 | HYDROmorphone HCl 1 MG in 1 ML Prefilled Syringe | PSN | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 1724644 | HYDROmorphone HCl 2 MG in 1 ML Cartridge | PSN | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 1724276 | HYDROmorphone HCl 2 MG in 1 ML Injection | PSN | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897757 | HYDROmorphone HCl 2 MG in 1 ML Prefilled Syringe | PSN | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897758 | HYDROmorphone HCl 4 MG in 1 ML Cartridge | PSN | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897753 | HYDROmorphone HCl 4 MG in 1 ML Injection | PSN | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 1724383 | 1 ML hydromorphone hydrochloride 1 MG/ML Cartridge | SCD | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897653 | 1 ML hydromorphone hydrochloride 1 MG/ML Injection | SCD | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897756 | 1 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe | SCD | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 1724644 | 1 ML hydromorphone hydrochloride 2 MG/ML Cartridge | SCD | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 1724276 | 1 ML hydromorphone hydrochloride 2 MG/ML Injection | SCD | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897757 | 1 ML hydromorphone hydrochloride 2 MG/ML Prefilled Syringe | SCD | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897758 | 1 ML hydromorphone hydrochloride 4 MG/ML Cartridge | SCD | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897753 | 1 ML hydromorphone hydrochloride 4 MG/ML Injection | SCD | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 1724383 | hydromorphone HCl 1 MG per 1 ML Cartridge | SY | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897653 | hydromorphone HCl 1 MG per 1 ML Injection | SY | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897756 | hydromorphone HCl 1 MG per 1 ML Prefilled Syringe | SY | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 1724644 | hydromorphone HCl 2 MG per 1 ML Cartridge | SY | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 1724276 | hydromorphone HCl 2 MG per 1 ML Injection | SY | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897757 | hydromorphone HCl 2 MG per 1 ML Prefilled Syringe | SY | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897758 | hydromorphone HCl 4 MG per 1 ML Cartridge | SY | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 897753 | hydromorphone HCl 4 MG per 1 ML Injection | SY | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 33 |
| 1433251 | HYDROmorphone HCl 0.5 MG in 0.5 ML Prefilled Syringe | PSN | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
| 1724383 | HYDROmorphone HCl 1 MG in 1 ML Cartridge | PSN | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
| 897756 | HYDROmorphone HCl 1 MG in 1 ML Prefilled Syringe | PSN | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
| 1724644 | HYDROmorphone HCl 2 MG in 1 ML Cartridge | PSN | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
| 897757 | HYDROmorphone HCl 2 MG in 1 ML Prefilled Syringe | PSN | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
| 2675350 | HYDROmorphone hydrochloride 0.25 MG in 0.5 ML Prefilled Syringe | PSN | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
| 2675350 | 0.5 ML hydromorphone hydrochloride 0.5 MG/ML Prefilled Syringe | SCD | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
| 1433251 | 0.5 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe | SCD | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
| 1724383 | 1 ML hydromorphone hydrochloride 1 MG/ML Cartridge | SCD | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
| 897756 | 1 ML hydromorphone hydrochloride 1 MG/ML Prefilled Syringe | SCD | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
| 1724644 | 1 ML hydromorphone hydrochloride 2 MG/ML Cartridge | SCD | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
| 897757 | 1 ML hydromorphone hydrochloride 2 MG/ML Prefilled Syringe | SCD | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
| 1433251 | hydromorphone HCl 0.5 MG per 0.5 ML Prefilled Syringe | SY | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
| 1724383 | hydromorphone HCl 1 MG per 1 ML Cartridge | SY | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
| 897756 | hydromorphone HCl 1 MG per 1 ML Prefilled Syringe | SY | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
| 1724644 | hydromorphone HCl 2 MG per 1 ML Cartridge | SY | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
| 897757 | hydromorphone HCl 2 MG per 1 ML Prefilled Syringe | SY | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
| 2675350 | hydromorphone hydrochloride 0.25 MG per 0.5 ML Prefilled Syringe | SY | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0409-1312-03 | 00409131203 | 1 mL in 1 CARTRIDGE | 1 ml | Historical | ||||
| 0409-1312-16 | 00409131216 | 1 mL in 1 SYRINGE | 1 ml | Historical | ||||
| 0409-1312-30 | 00409131230 | 10 CARTRIDGE in 1 CARTON (0409-1312-30) / 1 mL in 1 CARTRIDGE (0409-1312-03) | 10 cartridge | 2011-12-01 | 0000-00-00 | No | No | Current |
| 0409-1312-36 | 00409131236 | 10 SYRINGE in 1 CELLO PACK (0409-1312-36) / 1 mL in 1 SYRINGE (0409-1312-16) | 10 syringe | 2021-02-01 | 0000-00-00 | No | No | Current |