MITIGO
- Product NDC
- 66794-160
- 11-digit product format
- 667940160
- Labeler code
- 66794
- Product ID
- 66794-160_495a6a51-d35d-2b96-e063-6394a90ac5f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- INJECTION
- Route
- EPIDURAL; INTRATHECAL
- Labeler
- Piramal Critical Care, Inc.
- Application
- ANDA204393
- Marketing category
- ANDA
- Marketing start
- 2019-02-25
- Substance
- MORPHINE SULFATE
- Active strength
- 200 mg/20mL
- 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
- MITIGO
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MORPHINE SULFATE | 200 mg/20mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | X3P646A2J0 |
| Rxcui | 1731522, 1731998, 2055307, 2055311 |
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 |
|---|---|---|---|---|---|---|
| 66794-160-02 | MITIGO | 1 mL in 1 VIAL, SINGLE-USE | INJECTION | 1 | 19 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66794-160-02 | ML - Milliliter | 66794-160 | 37674373-c841-4432-87af-99945920dcdc | 1 | 2018-09-05 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2055307 | MITIGO 200 MG in 20 ML Injection | PSN | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
| 2055311 | MITIGO 500 MG in 20 ML Injection | PSN | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
| 1731998 | morphine sulfate 200 MG in 20 ML Injection | PSN | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
| 1731522 | morphine sulfate 500 MG in 20 ML Injection | PSN | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
| 2055307 | 20 ML morphine sulfate 10 MG/ML Injection [Mitigo] | SBD | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
| 2055311 | 20 ML morphine sulfate 25 MG/ML Injection [Mitigo] | SBD | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
| 1731998 | 20 ML morphine sulfate 10 MG/ML Injection | SCD | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
| 1731522 | 20 ML morphine sulfate 25 MG/ML Injection | SCD | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
| 2055307 | 20 ML Mitigo 10 MG/ML Injection | SY | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
| 2055311 | 20 ML Mitigo 25 MG/ML Injection | SY | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
| 1731998 | 20 ML MS 10 MG/ML Injection | SY | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
| 2055307 | 20 ML MS 10 MG/ML Injection [Mitigo] | SY | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
| 1731522 | 20 ML MS 25 MG/ML Injection | SY | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
| 2055311 | 20 ML MS 25 MG/ML Injection [Mitigo] | SY | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
| 2055307 | Mitigo 200 MG per 20 ML Injection | SY | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
| 2055311 | Mitigo 500 MG per 20 ML Injection | SY | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
| 1731998 | morphine sulfate 200 MG per 20 ML Injection | SY | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
| 1731522 | morphine sulfate 500 MG per 20 ML Injection | SY | 728f3d83-9a63-0c1f-e053-2a91aa0ac7db | 19 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 66794-160-02 | 66794016002 | 1 mL in 1 VIAL, SINGLE-USE (66794-160-02) | 1 ml | 2019-02-25 | 0000-00-00 | No | No | Current |