What is NDC 58657-418?

58657-418 is the product NDC for Esterified Estrogens And Methyltestosterone Half Strength, Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1 tablet, listed with the FDA by Method Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Esterified Estrogens And Methyltestosterone Half Strength (Esterified estrogens, Methyltestosterone).

What is the active ingredient?

Estrogens, Esterified, Methyltestosterone.

Method Pharmaceuticals, LLC, NDC labeler code 58657. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Esterified Estrogens And Methyltestosterone Half Strength?

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.

NDC 58657-418

NDC codes

FDA NDC Directory

Product NDC (as listed)58657-418Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58657-0418Add 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
58657-418-01	5865704180158657041801	100 TABLET in 1 BOTTLE (58657-418-01)Marketed from Mar 10, 2025

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): Esterified Estrogens And Methyltestosterone Half Strength
Generic name (nonproprietary): esterified estrogens, methyltestosterone
Active ingredients: Estrogens, Esterified — .625 mg/1Methyltestosterone — 1.25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Method Pharmaceuticals, LLCNDC labeler code 58657
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Mar 10, 2025
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers: Product ID 58657-418_30a68873-f9ef-4de8-e063-6394a90ab5a4SPL ID 30a68873-f9ef-4de8-e063-6394a90ab5a4SPL set ID 2ff36c19-8112-8db3-e063-6394a90a04c6RxCUI 197670, 238006UNII V9EFU16ZIF, 3ASP8Q3768UPC 0358657419011, 0358657418014
Pharmacologic class: Androgen

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

N458657041801 followed by a unit qualifier and the quantity

Package 58657-0418-01. 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 Mar 10, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH are indicated in the treatment of: Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.) ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM T…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58657-418

What is NDC 58657-418?: 58657-418 is the product NDC for Esterified Estrogens And Methyltestosterone Half Strength, Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1 tablet, listed with the FDA by Method Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Esterified Estrogens And Methyltestosterone Half Strength (Esterified estrogens, Methyltestosterone).
What is the active ingredient?: Estrogens, Esterified, Methyltestosterone.
Who is the labeler?: Method Pharmaceuticals, LLC, NDC labeler code 58657. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Esterified Estrogens And Methyltestosterone Half Strength?: 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.

Esterified Estrogens And Methyltestosterone Half Strength (Esterified estrogens, methyltestosterone) NDC 58657-418