Prescription drug · NDA
Seysara (Sarecycline hydrochloride) NDC 16110-245
Sarecycline hydrochloride 60 mg/1 · Tablet, Coated · Oral · Almirall, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16110-245-30 | 16110024530 | 30 TABLET, COATED in 1 BOTTLE (16110-245-30)Marketed from Jan 4, 2019 |
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)
- Seysara
- Generic name (nonproprietary)
- sarecycline hydrochloride
- Active ingredients
- Sarecycline hydrochloride — 60 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Almirall, LLCNDC labeler code 16110
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209521
- Marketing start
- Listing expires
- Other FDA classes
- P-Glycoprotein Inhibitors (Mechanism)Tetracyclines (Chemical structure)
- Identifiers
- Product ID 16110-245_4f9be4df-4e12-4f08-8e6f-cb07926ea5e6SPL ID 4f9be4df-4e12-4f08-8e6f-cb07926ea5e6SPL set ID b200957c-3004-4988-be97-9fd619a83649RxCUI 2059023, 2059029, 2059031, 2059033, 2059035, 2059037UNII 36718856JRUPC 0316110245300, 0316110246307
- Pharmacologic class
- Tetracycline-class Drug
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
N416110024530followed by a unit qualifier and the quantityPackage 16110-0245-30. 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)
SEYSARA ® (sarecycline) tablet, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Limitations of Use Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established. SEYSARA has not been evaluated in the treatment of infections [see Clinical Studies ( 14 )] . To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SEYSARA should be used only as indicated [see Warnings and Precautions ( 5.6 )] . SEYSARA ® is a tetracycline-class drug indicated for the treatment of inflammatory lesions of non-nodular moderate to…
Excerpt only. Read the full label for complete information.
About NDC 16110-245
- What is NDC 16110-245?
- 16110-245 is the product NDC for Seysara (sarecycline hydrochloride), Sarecycline hydrochloride 60 mg/1 tablet, coated, listed with the FDA by Almirall, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Seysara (Sarecycline hydrochloride).
- What is the active ingredient?
- Sarecycline hydrochloride.
- Who is the labeler?
- Almirall, LLC, NDC labeler code 16110. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Seysara?
- 1 other product NDC are listed under this name. See all Seysara NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Seysara products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Seysarasarecycline hydrochloride | Sarecycline hydrochloride 100 mg/1 | Tablet, CoatedOral | Almirall, LLC | 16110-246 | 16110-0246-30 |
| Seysarasarecycline hydrochloride | Sarecycline hydrochloride 150 mg/1 | Tablet, CoatedOral | Almirall, LLC | 16110-247 | 16110-0247-30 |
Other NDCs under NDA 209521
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 |
|---|---|---|---|---|
| Seysarasarecycline hydrochloride | Sarecycline hydrochloride 100 mg/1 | Tablet, CoatedOral | Almirall, LLC | 16110-246 |
| Seysarasarecycline hydrochloride | Sarecycline hydrochloride 150 mg/1 | Tablet, CoatedOral | Almirall, LLC | 16110-247 |