Prescription drug · NDA
Movantik (Naloxegol oxalate) NDC 57841-1301
Naloxegol oxalate 25 mg/1 · Tablet, Film coated · Oral · RedHill Biopharma Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57841-1301-1 | 5784113010157841130101 | 30 TABLET, FILM COATED in 1 BOTTLE (57841-1301-1)Marketed from Oct 1, 2020 | |
| 57841-1301-2 | 5784113010257841130102 | 90 TABLET, FILM COATED in 1 BOTTLE (57841-1301-2)Marketed from Oct 1, 2020 | |
| 57841-1301-3 | 5784113010357841130103 | 10 BLISTER PACK in 1 CARTON (57841-1301-3) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 1, 2020 | |
| 57841-1301-4 | 5784113010457841130104 | 1 BLISTER PACK in 1 CARTON (57841-1301-4) / 3 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 1, 2020 · Sample package |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Movantik
- Generic name (nonproprietary)
- naloxegol oxalate
- Active ingredients
- Naloxegol oxalate — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- RedHill Biopharma LtdNDC labeler code 57841
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204760
- Marketing start
- Marketing end
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 57841-1301_27e98e6d-9faf-3a94-e063-6394a90a1dcbSPL ID 27e98e6d-9faf-3a94-e063-6394a90a1dcbSPL set ID 300a6474-ebcd-4404-8040-48fdcfcc1635RxCUI 1551782, 1551917, 1551923, 1601373UNII 65I14TNM33UPC 0357841130114, 0357841130015
- Pharmacologic class
- Opioid Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N457841130101followed by a unit qualifier and the quantityPackage 57841-1301-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
MOVANTIK ® is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. MOVANTIK is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. (1)
Excerpt only. Read the full label for complete information.
About NDC 57841-1301
- What is NDC 57841-1301?
- 57841-1301 is the product NDC for Movantik (naloxegol oxalate), Naloxegol oxalate 25 mg/1 tablet, film coated, listed with the FDA by RedHill Biopharma Ltd. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Movantik (Naloxegol oxalate).
- What is the active ingredient?
- Naloxegol oxalate.
- Who is the labeler?
- RedHill Biopharma Ltd, NDC labeler code 57841. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Movantik?
- 2 other product NDCs are listed under this name. See all Movantik NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Movantik products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Movantiknaloxegol oxalate | Naloxegol oxalate 12.5 mg/1 | Tablet, Film coatedOral | Averitas Pharma, Inc. | 82625-8801 | 82625-8801-0182625-8801-0282625-8801-03+1 more |
| Movantiknaloxegol oxalate | Naloxegol oxalate 25 mg/1 | Tablet, Film coatedOral | Averitas Pharma, Inc. | 82625-8802 | 82625-8802-0182625-8802-0282625-8802-03+1 more |
Other NDCs under NDA 204760
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Movantiknaloxegol oxalate | Naloxegol oxalate 12.5 mg/1 | Tablet, Film coatedOral | Averitas Pharma, Inc. | 82625-8801 |
| Movantiknaloxegol oxalate | Naloxegol oxalate 25 mg/1 | Tablet, Film coatedOral | Averitas Pharma, Inc. | 82625-8802 |