What is NDC 58468-0030?

58468-0030 is the product NDC for Thyrogen (thyrotropin alfa), Thyrotropin alfa .9 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Genzyme Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.

Genzyme Corporation, NDC labeler code 58468. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Thyrogen?

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.

Thyrogen NDC 58468-0030 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58468-0030Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58468-0030Add 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
58468-0030-2	58468003002	2 VIAL, SINGLE-DOSE in 1 CARTON (58468-0030-2) / 1 mL in 1 VIAL, SINGLE-DOSE (58468-0030-1)Marketed from Nov 30, 1998

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): Thyrogen
Generic name (nonproprietary): thyrotropin alfa
Active ingredients: Thyrotropin alfa — .9 mg/mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intramuscular
Labeler: Genzyme CorporationNDC labeler code 58468
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 020898
Marketing start: Nov 30, 1998
Listing expires: Dec 31, 2026
Other FDA classes: Thyrotropin (Chemical structure)
Identifiers: Product ID 58468-0030_a62de867-ea60-47eb-873a-788223a1181fSPL ID a62de867-ea60-47eb-873a-788223a1181fSPL set ID b52dfa36-f90b-4e19-9b5e-26db9d04df2bRxCUI 2166572, 2166573, 2166578, 2166579, 2554801, 2554802, 2554804, 2554805UNII AVX3D5A4LM
Pharmacologic class: Thyroid Stimulating Hormone

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

N458468003002 followed by a unit qualifier and the quantity

Package 58468-0030-02. 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 24, 2023.

Indications (excerpt from the label)

THYROGEN ® is a thyroid stimulating hormone indicated for: Adjunctive Diagnostic Tool for Well-Differentiated Thyroid Cancer: Use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy. ( 1.1 ) Limitations of Use : THYROGEN-stimulated Tg levels are generally lower than, and do not correlate with Tg levels after thyroid hormone withdrawal. Even when THYROGEN-Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or underestimating the extent of the disease. Ant…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58468-0030

What is NDC 58468-0030?: 58468-0030 is the product NDC for Thyrogen (thyrotropin alfa), Thyrotropin alfa .9 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Genzyme Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Thyrogen (Thyrotropin alfa).
What is the active ingredient?: Thyrotropin alfa.
Who is the labeler?: Genzyme Corporation, NDC labeler code 58468. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Thyrogen?: 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.

Thyrogen (Thyrotropin alfa) NDC 58468-0030