What is NDC 71390-011?

71390-011 is the product NDC for Byfavo (remimazolam besylate), Remimazolam besylate 2.5 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Acacia Pharma, Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.

Acacia Pharma, Ltd., NDC labeler code 71390. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Byfavo?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Byfavo NDC 71390-011 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71390-011Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71390-0011Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
71390-011-11	71390001111	10 VIAL in 1 CARTON (71390-011-11) / 8 mL in 1 VIAL (71390-011-00)Marketed from Oct 6, 2020

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): Byfavo
Generic name (nonproprietary): remimazolam besylate
Active ingredients: Remimazolam besylate — 2.5 mg/mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Acacia Pharma, Ltd.NDC labeler code 71390
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 212295
Marketing start: Oct 6, 2020
Listing expires: Dec 31, 2026
DEA schedule: CIV
Identifiers: Product ID 71390-011_4da618a9-2e04-4d75-922b-173d22b4e84cSPL ID 4da618a9-2e04-4d75-922b-173d22b4e84cSPL set ID 4e1838f2-b999-41a7-a761-d94f09aa531fRxCUI 2383946, 2383951UNII 280XQ6482HUPC 0371390011007

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N471390001111 followed by a unit qualifier and the quantity

Package 71390-0011-11. 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 Feb 20, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

BYFAVO ® is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. BYFAVO (remimazolam) for injection is a benzodiazepine indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71390-011

What is NDC 71390-011?: 71390-011 is the product NDC for Byfavo (remimazolam besylate), Remimazolam besylate 2.5 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Acacia Pharma, Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Byfavo (Remimazolam besylate).
What is the active ingredient?: Remimazolam besylate.
Who is the labeler?: Acacia Pharma, Ltd., NDC labeler code 71390. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Byfavo?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Byfavo (Remimazolam besylate) NDC 71390-011