Prescription drug · NDA
Hysingla ER (hydrocodone bitartrate) NDC 59011-275
Hydrocodone bitartrate 80 mg/1 · Tablet, Extended release · Oral · Knoa Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59011-275-60 | 59011027560 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-275-60)Marketed from Jan 15, 2015 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Hysingla ER
- Generic name (nonproprietary)
- hydrocodone bitartrate
- Active ingredients
- Hydrocodone bitartrate — 80 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Knoa Pharma LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206627
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 59011-275_556f1138-72ae-4693-ba62-75df59060197SPL ID 556f1138-72ae-4693-ba62-75df59060197SPL set ID b7d23ac2-e776-9f62-3290-c64c2d6eb353RxCUI 1595730, 1595736, 1595740, 1595742, 1595746, 1595748, 1595752, 1595754, 1595758, 1595760, 1595764, 1595766UNII NO70W886KKUPC 0359011273607, 0359011276608, 0359011272600, 0359011274604, 0359011271603, 0359011275601
- Pharmacologic class
- Opioid Agonist
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
N459011027560followed by a unit qualifier and the quantityPackage 59011-0275-60. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
HYSINGLA ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ] , reserve opioid analgesics, including HYSINGLA ER, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. HYSINGLA ER is not indicated as an as-needed (prn) analgesic. HYS…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 206627
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 |
|---|---|---|---|---|
| Hysingla ERhydrocodone bitartrate | Hydrocodone bitartrate 30 mg/1 | Tablet, Extended releaseOral | Knoa Pharma LLC | 59011-272 |
| Hysingla ERhydrocodone bitartrate | Hydrocodone bitartrate 20 mg/1 | Tablet, Extended releaseOral | Knoa Pharma LLC | 59011-271 |
| Hysingla ERhydrocodone bitartrate | Hydrocodone bitartrate 40 mg/1 | Tablet, Extended releaseOral | Knoa Pharma LLC | 59011-273 |
| Hysingla ERhydrocodone bitartrate | Hydrocodone bitartrate 60 mg/1 | Tablet, Extended releaseOral | Knoa Pharma LLC | 59011-274 |
| Hysingla ERhydrocodone bitartrate | Hydrocodone bitartrate 100 mg/1 | Tablet, Extended releaseOral | Knoa Pharma LLC | 59011-276 |