Duramorph
- Product NDC
- 0641-6020
- 11-digit product format
- 006416020
- Labeler code
- 0641
- Product ID
- 0641-6020_aa74af85-7068-4254-9a79-c7f3792044a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- morphine sulfate
- Dosage form
- INJECTION
- Route
- EPIDURAL; INTRATHECAL; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA018565
- Marketing category
- NDA
- Marketing start
- 1984-09-18
- Substance
- MORPHINE SULFATE
- Active strength
- .5 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
- Duramorph
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MORPHINE SULFATE | .5 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | X3P646A2J0 |
| Rxcui | 892473, 892489, 1728783, 1728800 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 89941d4c-522d-cee0-b273-43cfa7ef6d35 | Product name | 4 | 20250516 |
| f15f9e76-db42-8a50-218a-5ef5affa58da | Product name | 4 | 20240216 |
| 944b0689-73f4-6a2f-c654-1180896353c0 | Product name | 4 | 20220210 |
| 67e166c6-23d4-4709-b77d-5ca6182dcae0 | Product name | 1 | 20180830 |
| c573a64c-fe17-2eac-fbcb-788868b4ff6b | Product name | 9 | 20180619 |
| 7c1819cf-69a0-41dc-aeaa-a820729bc959 | Product name | 1 | 20170406 |
| 7a68fc31-10e5-df04-67e0-3a613a2d4d2e | Product name | 5 | 20161114 |
| 175682a8-c657-45a2-9dfb-c565306b03c8 | Product name | 1 | 20160112 |
| b73dadd0-1b4a-4f88-956f-a2be216c8fad | Product name | 1 | 20151123 |
| 4c272b1c-87fc-ebc0-994d-ac28b1e0416e | Product name | 1 | 20140508 |
| 7a537f54-d322-5e54-a3a2-035d3e21c3c6 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0641-6020-01 | Duramorph | 10 mL in 1 AMPULE | INJECTION | 10 | 11 | |
| 0641-6020-10 | Duramorph | 10 in 1 CARTON | INJECTION | 10 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-6020-01 | ML - Milliliter | 0641-6020 | ae81d415-ce60-4b56-a87a-de509b5609a0 | 1 | 2013-02-13 |
| 0641-6020-10 | ML - Milliliter | 0641-6020 | c1007f62-874c-447f-be7b-0a6145d0d0c8 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MORPHINE SULFATE | ACTIVE INGREDIENT | X3P646A2J0 | DURAMORPH (MORPHINE SULFATE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 3 | |
| MORPHINE | ACTIVE MOIETY | 76I7G6D29C | DURAMORPH (MORPHINE SULFATE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 3 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | DURAMORPH (MORPHINE SULFATE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DURAMORPH (MORPHINE SULFATE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 892489 | Duramorph 10 MG in 10 ML Injection | PSN | ebb18761-e5c4-4238-bb84-f9549f500210 | 11 |
| 892473 | Duramorph 5 MG in 10 ML Injection | PSN | ebb18761-e5c4-4238-bb84-f9549f500210 | 11 |
| 1728800 | morphine sulfate 10 MG in 10 ML Injection | PSN | ebb18761-e5c4-4238-bb84-f9549f500210 | 11 |
| 1728783 | morphine sulfate 5 MG in 10 ML Injection | PSN | ebb18761-e5c4-4238-bb84-f9549f500210 | 11 |
| 892473 | 10 ML morphine sulfate 0.5 MG/ML Injection [Duramorph] | SBD | ebb18761-e5c4-4238-bb84-f9549f500210 | 11 |
| 892489 | 10 ML morphine sulfate 1 MG/ML Injection [Duramorph] | SBD | ebb18761-e5c4-4238-bb84-f9549f500210 | 11 |
| 1728783 | 10 ML morphine sulfate 0.5 MG/ML Injection | SCD | ebb18761-e5c4-4238-bb84-f9549f500210 | 11 |
| 1728800 | 10 ML morphine sulfate 1 MG/ML Injection | SCD | ebb18761-e5c4-4238-bb84-f9549f500210 | 11 |
| 1728783 | 10 ML MS 0.5 MG/ML Injection | SY | ebb18761-e5c4-4238-bb84-f9549f500210 | 11 |
| 892473 | 10 ML MS 0.5 MG/ML Injection [Duramorph] | SY | ebb18761-e5c4-4238-bb84-f9549f500210 | 11 |
| 1728800 | 10 ML MS 1 MG/ML Injection | SY | ebb18761-e5c4-4238-bb84-f9549f500210 | 11 |
| 892489 | 10 ML MS 1 MG/ML Injection [Duramorph] | SY | ebb18761-e5c4-4238-bb84-f9549f500210 | 11 |
| 892489 | Duramorph 10 MG per 10 ML Injection | SY | ebb18761-e5c4-4238-bb84-f9549f500210 | 11 |
| 892473 | Duramorph 5 MG per 10 ML Injection | SY | ebb18761-e5c4-4238-bb84-f9549f500210 | 11 |
| 1728800 | morphine sulfate 10 MG per 10 ML Injection | SY | ebb18761-e5c4-4238-bb84-f9549f500210 | 11 |
| 1728783 | morphine sulfate 5 MG per 10 ML Injection | SY | ebb18761-e5c4-4238-bb84-f9549f500210 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0641-6020-01 | 00641602001 | 10 mL in 1 AMPULE | 10 ml | Historical | ||||
| 0641-6020-10 | 00641602010 | 10 AMPULE in 1 CARTON (0641-6020-10) / 10 mL in 1 AMPULE (0641-6020-01) | 10 ampule | 1984-09-18 | 0000-00-00 | No | No | Current |