MOVANTIK
- Product NDC
- 57841-1301
- 11-digit product format
- 578411301
- Labeler code
- 57841
- Product ID
- 57841-1301_27e98e6d-9faf-3a94-e063-6394a90a1dcb
- 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
- 2027-01-31
- Substance
- NALOXEGOL OXALATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MOVANTIK
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NALOXEGOL OXALATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 65I14TNM33 |
| Rxcui | 1551782, 1551917, 1551923, 1601373 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57841-1301-1 | MOVANTIK | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 57841-1301-2 | MOVANTIK | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
| 57841-1301-3 | MOVANTIK | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 5 |
| 57841-1301-3 | MOVANTIK | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 5 |
| 57841-1301-4 | MOVANTIK | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 5 |
| 57841-1301-4 | 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 |
|---|
| 57841-1301 | MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [REDHILL BIOPHARMA LTD] | 5 | Current NDC, 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 |
|---|
| 57841-1301-1 | 57841130101 | 30 TABLET, FILM COATED in 1 BOTTLE (57841-1301-1) | | 2020-10-01 | 2027-01-31 | No | No | Current |
| 57841-1301-2 | 57841130102 | 90 TABLET, FILM COATED in 1 BOTTLE (57841-1301-2) | | 2020-10-01 | 2027-01-31 | No | No | Current |
| 57841-1301-3 | 57841130103 | 10 BLISTER PACK in 1 CARTON (57841-1301-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2020-10-01 | 2027-01-31 | No | No | Current |
| 57841-1301-4 | 57841130104 | 1 BLISTER PACK in 1 CARTON (57841-1301-4) / 3 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2020-10-01 | 2027-01-31 | Yes | No | Current |