What is NDC 58160-740?

58160-740 is the product NDC for Rotarix, Human rotavirus a type g1p(8) strain rix4414 live antigen 1000 [CCID_50]/mL solution, listed with the FDA by GlaxoSmithKline Biologicals SA. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Rotarix (Rotavirus Vaccine, Live, Oral).

What is the active ingredient?

Human rotavirus a type g1p(8) strain rix4414 live antigen.

GlaxoSmithKline Biologicals SA, NDC labeler code 58160. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Rotarix?

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.

Rotarix NDC 58160-740 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58160-740Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58160-0740Add 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
58160-740-21	5816007402158160074021	10 APPLICATOR in 1 CARTON (58160-740-21) / 1.5 mL in 1 APPLICATOR (58160-740-02)Marketed from Feb 1, 2023

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): Rotarix
Generic name (nonproprietary): rotavirus vaccine, live, oral
Active ingredients: Human rotavirus a type g1p(8) strain rix4414 live antigen — 1000 [CCID_50]/mL
Dosage form: Solution
Route: Oral
Labeler: GlaxoSmithKline Biologicals SANDC labeler code 58160
Product type: Vaccine
Marketing category: BLA — Biologics License ApplicationApplication BLA 125265
Marketing start: Feb 1, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Actively Acquired Immunity (Physiologic effect)Rotavirus Vaccines (Chemical structure)Attenuated (Chemical structure)
Identifiers: Product ID 58160-740_ee0a0828-9acd-441a-8cc5-8e3e47bcaa80SPL ID ee0a0828-9acd-441a-8cc5-8e3e47bcaa80
Pharmacologic class: Live Attenuated Rotavirus Vaccine

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.

Administration

Immunization administration (CPT 90460–90474)

Giving a vaccine is reported separately from the vaccine product code, with an immunization administration code. Which code applies depends on the patient's age, the route and whether counselling was provided.

How CPT relates to drug billing

NDC on a medical claim

N458160074021 followed by a unit qualifier and the quantity

Package 58160-0740-21. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 58160-740

What is NDC 58160-740?: 58160-740 is the product NDC for Rotarix, Human rotavirus a type g1p(8) strain rix4414 live antigen 1000 [CCID_50]/mL solution, listed with the FDA by GlaxoSmithKline Biologicals SA. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Rotarix (Rotavirus Vaccine, Live, Oral).
What is the active ingredient?: Human rotavirus a type g1p(8) strain rix4414 live antigen.
Who is the labeler?: GlaxoSmithKline Biologicals SA, NDC labeler code 58160. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Rotarix?: 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.

Rotarix (Rotavirus vaccine, live, oral) NDC 58160-740