MOVANTIK
- Product NDC
- 57841-1300
- 11-digit product format
- 578411300
- Labeler code
- 57841
- Product ID
- 57841-1300_046d2fd8-3056-425f-a196-7ff77450368c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naloxegol oxalate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RedHill Biopharma Ltd
- Application
- NDA204760
- Marketing category
- NDA
- Marketing start
- 2020-10-01
- Marketing end
- 0000-00-00
- Substance
- NALOXEGOL OXALATE
- Active strength
- 13 mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57841-1300-1 | MOVANTIK | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 57841-1300-2 | MOVANTIK | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
| 57841-1300-3 | MOVANTIK | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 5 |
| 57841-1300-3 | MOVANTIK | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 5 |
| 57841-1300-4 | MOVANTIK | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 5 |
| 57841-1300-4 | MOVANTIK | 3 in 1 BLISTER PACK | TABLET, FILM COATED | 3 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57841-1300 | MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [REDHILL BIOPHARMA LTD] | 5 | Legacy NDC, 6 package rows | 20241129_300a6474-ebcd-4404-8040-48fdcfcc1635.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57841-1300-1 | 57841130001 | 30 TABLET, FILM COATED in 1 BOTTLE (57841-1300-1) | | 2020-10-01 | 0000-00-00 | No | No | Current |
| 57841-1300-2 | 57841130002 | 90 TABLET, FILM COATED in 1 BOTTLE (57841-1300-2) | | 2020-10-01 | 0000-00-00 | No | No | Current |
| 57841-1300-3 | 57841130003 | 10 BLISTER PACK in 1 CARTON (57841-1300-3) > 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2020-10-01 | 0000-00-00 | No | No | Current |
| 57841-1300-4 | 57841130004 | 1 BLISTER PACK in 1 CARTON (57841-1300-4) > 3 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2020-10-01 | 0000-00-00 | Yes | No | Current |