EMBEDA
- Product NDC
- 60793-430
- 11-digit product format
- 607930430
- Labeler code
- 60793
- Product ID
- 60793-430_c44a9425-3894-424f-9f60-cbf08d358e3e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA022321
- Marketing category
- NDA
- Marketing start
- 2009-08-13
- Marketing end
- 0000-00-00
- Substance
- MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
- Active strength
- 20 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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 |
| 31849934-38d8-47fe-b84a-4d392838c14b | Product name | 1 | 20170823 |
| 7c1819cf-69a0-41dc-aeaa-a820729bc959 | Product name | 1 | 20170406 |
| 7a68fc31-10e5-df04-67e0-3a613a2d4d2e | Product name | 5 | 20161114 |
| 8e48b6b8-3a2f-4e0d-b7c9-38d70393b778 | Product name | 1 | 20161103 |
| 175682a8-c657-45a2-9dfb-c565306b03c8 | Product name | 1 | 20160112 |
| b73dadd0-1b4a-4f88-956f-a2be216c8fad | Product name | 1 | 20151123 |
| e4d463bc-c674-43cb-be06-82786f310d01 | Product name | 1 | 20150326 |
| 4c272b1c-87fc-ebc0-994d-ac28b1e0416e | Product name | 1 | 20140508 |
| 7a537f54-d322-5e54-a3a2-035d3e21c3c6 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60793-430-01 | EA - Each | 60793-430 | cc2c8011-8904-4dcb-b56a-d7ca70d9b3ec | 1 | 2012-07-24 |
| 60793-430-20 | EA - Each | 60793-430 | ec48738c-8b90-405d-994b-7cd36f42aa13 | 1 | 2015-02-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MORPHINE SULFATE | ACTIVE INGREDIENT | X3P646A2J0 | EMBEDA (MORPHINE SUFATE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| NALTREXONE HYDROCHLORIDE | ACTIVE INGREDIENT | Z6375YW9SF | EMBEDA (MORPHINE SUFATE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| MORPHINE | ACTIVE MOIETY | 76I7G6D29C | EMBEDA (MORPHINE SUFATE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| NALTREXONE | ACTIVE MOIETY | 5S6W795CQM | EMBEDA (MORPHINE SUFATE) CAPSULE, EXTENDED RELEASE [STAT RX USA LLC] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 863849 | EMBEDA 20 MG / 0.8 MG Extended Release Oral Capsule | PSN | dfe97a3d-247d-4dda-a641-1a95196cd8d8 | 1 |
| 863848 | morphine sulfate 20 MG / naltrexone HCl 0.8 MG Extended Release Oral Capsule, Abuse-Deterrent | PSN | dfe97a3d-247d-4dda-a641-1a95196cd8d8 | 1 |
| 863849 | Abuse-Deterrent morphine sulfate 20 MG / naltrexone hydrochloride 0.8 MG Extended Release Oral Capsule [Embeda] | SBD | dfe97a3d-247d-4dda-a641-1a95196cd8d8 | 1 |
| 863848 | Abuse-Deterrent morphine sulfate 20 MG / naltrexone hydrochloride 0.8 MG Extended Release Oral Capsule | SCD | dfe97a3d-247d-4dda-a641-1a95196cd8d8 | 1 |
| 863848 | Abuse-Deterrent MS 20 MG / Naltrexone hydrochloride 0.8 MG Extended Release Oral Capsule | SY | dfe97a3d-247d-4dda-a641-1a95196cd8d8 | 1 |
| 863849 | Abuse-Deterrent MS 20 MG / Naltrexone hydrochloride 0.8 MG Extended Release Oral Capsule [Embeda] | SY | dfe97a3d-247d-4dda-a641-1a95196cd8d8 | 1 |
| 863849 | Embeda (morphine sulfate 20 MG / naltrexone hydrochloride 0.8 MG) Extended Release Oral Capsule | SY | dfe97a3d-247d-4dda-a641-1a95196cd8d8 | 1 |
| 863848 | morphine sulfate 20 MG / naltrexone HCl 0.8 MG Extended Release Oral Capsule, Abuse-Deterrent | SY | dfe97a3d-247d-4dda-a641-1a95196cd8d8 | 1 |