INFUMORPH 500
- Product NDC
- 0641-6040
- 11-digit product format
- 006416040
- Labeler code
- 0641
- Product ID
- 0641-6040_b1c060cb-5c5b-495f-90b5-044e04f2a3f2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- morphine sulfate
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INTRATHECAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA018565
- Marketing category
- NDA
- Marketing start
- 1984-09-18
- Substance
- MORPHINE SULFATE
- Active strength
- 25 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
- INFUMORPH 500
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MORPHINE SULFATE | 25 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | X3P646A2J0 |
| Rxcui | 892652, 1731522, 1731998, 1731999 |
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 |
|---|---|---|---|---|---|---|
| 0641-6040-01 | INFUMORPH 500 | 20 mL in 1 AMPULE | INJECTION, SOLUTION | 20 | 12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0641-6040 | INFUMORPH 200 (MORPHINE SULFATE) INJECTION, SOLUTION INFUMORPH 500 (MORPHINE SULFATE) INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 11 | Current NDC, Legacy NDC, 1 package rows | 20240411_db9ac9e3-d761-4a99-9f34-4946ebe8f255.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1731999 | INFUMORPH 200 MG in 20 ML Injection | PSN | db9ac9e3-d761-4a99-9f34-4946ebe8f255 | 12 |
| 892652 | INFUMORPH 500 MG in 20 ML Injection | PSN | db9ac9e3-d761-4a99-9f34-4946ebe8f255 | 12 |
| 1731998 | morphine sulfate 200 MG in 20 ML Injection | PSN | db9ac9e3-d761-4a99-9f34-4946ebe8f255 | 12 |
| 1731522 | morphine sulfate 500 MG in 20 ML Injection | PSN | db9ac9e3-d761-4a99-9f34-4946ebe8f255 | 12 |
| 1731999 | 20 ML morphine sulfate 10 MG/ML Injection [Infumorph] | SBD | db9ac9e3-d761-4a99-9f34-4946ebe8f255 | 12 |
| 892652 | 20 ML morphine sulfate 25 MG/ML Injection [Infumorph] | SBD | db9ac9e3-d761-4a99-9f34-4946ebe8f255 | 12 |
| 1731998 | 20 ML morphine sulfate 10 MG/ML Injection | SCD | db9ac9e3-d761-4a99-9f34-4946ebe8f255 | 12 |
| 1731522 | 20 ML morphine sulfate 25 MG/ML Injection | SCD | db9ac9e3-d761-4a99-9f34-4946ebe8f255 | 12 |
| 1731998 | 20 ML MS 10 MG/ML Injection | SY | db9ac9e3-d761-4a99-9f34-4946ebe8f255 | 12 |
| 1731999 | 20 ML MS 10 MG/ML Injection [Infumorph] | SY | db9ac9e3-d761-4a99-9f34-4946ebe8f255 | 12 |
| 1731522 | 20 ML MS 25 MG/ML Injection | SY | db9ac9e3-d761-4a99-9f34-4946ebe8f255 | 12 |
| 892652 | 20 ML MS 25 MG/ML Injection [Infumorph] | SY | db9ac9e3-d761-4a99-9f34-4946ebe8f255 | 12 |
| 1731999 | Infumorph 200 MG per 20 ML Injection | SY | db9ac9e3-d761-4a99-9f34-4946ebe8f255 | 12 |
| 892652 | Infumorph 500 MG per 20 ML Injection | SY | db9ac9e3-d761-4a99-9f34-4946ebe8f255 | 12 |
| 1731998 | morphine sulfate 200 MG per 20 ML Injection | SY | db9ac9e3-d761-4a99-9f34-4946ebe8f255 | 12 |
| 1731522 | morphine sulfate 500 MG per 20 ML Injection | SY | db9ac9e3-d761-4a99-9f34-4946ebe8f255 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0641-6040-01 | 00641604001 | 20 mL in 1 AMPULE (0641-6040-01) | 20 ml | 1984-09-18 | 0000-00-00 | No | No | Current |