What is NDC 53746-077?

53746-077 is the product NDC for Esterified Estrogens and Methyltestosterone, Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Estrogens, Esterified, Methyltestosterone.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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?

17 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Esterified Estrogens and Methyltestosterone NDC 53746-077

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-077Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0077Add 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
53746-077-01	53746007701	100 TABLET in 1 BOTTLE (53746-077-01)Marketed from Sep 22, 2010

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
Generic name (nonproprietary): esterified estrogens and methyltestosterone
Active ingredients: Estrogens, Esterified — .625 mg/1Methyltestosterone — 1.25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 53746
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Sep 22, 2010
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers: Product ID 53746-077_c2c9cf77-504d-4d7c-8899-c3cb6f76c545SPL ID c2c9cf77-504d-4d7c-8899-c3cb6f76c545SPL set ID 316650b7-5770-4f1a-867d-68a72c60c8f2RxCUI 197670, 238006UNII V9EFU16ZIF, 3ASP8Q3768UPC 0353746078018, 0353746077011
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

N453746007701 followed by a unit qualifier and the quantity

Package 53746-0077-01. 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 Dec 31, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Esterified Estrogens and Methyltestosterone Tablets and Esterified Estrogens and Methyltestosterone Tablets H.S. 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 Tablets and Esterified Estrogens and Methyltestosterone Tablets H.S. have not been shown to be effective for any purpose during pregnancy and its use may cause severe harm to the fetus.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53746-077

What is NDC 53746-077?: 53746-077 is the product NDC for Esterified Estrogens and Methyltestosterone, Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York 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.
What is the active ingredient?: Estrogens, Esterified, Methyltestosterone.
Who is the labeler?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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?: 17 other product NDCs are listed under this name. See all Esterified Estrogens and Methyltestosterone NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Esterified Estrogens and Methyltestosterone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Esterified Estrogens And Methyltestosteroneesterified estrogens, methyltestosterone	Estrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1	TabletOral	Bryant Ranch Prepack	72162-2393	72162-2393-01
Esterified Estrogens And Methyltestosteroneesterified estrogens, methyltestosterone	Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-407	58657-0407-01
Esterified Estrogens And Methyltestosteroneesterified estrogens, methyltestosterone	Estrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1	TabletOral	Method Pharmaceuticals, LLC	58657-408	58657-0408-01
Esterified Estrogens and Methyltestosteroneesterified estrogens, methyltestosterone	Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1	TabletOral	STATUS PROJECTS PRIVATE LIMITED	84346-450	84346-0450-01
Esterified Estrogens And Methyltestosteroneesterified estrogens, methyltestosterone	Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1	TabletOral	Leading Pharmaceuticals, LLC	69315-283	69315-0283-01
Esterified Estrogens And Methyltestosteroneesterified estrogens, methyltestosterone	Estrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1	TabletOral	Leading Pharmaceuticals, LLC	69315-284	69315-0284-01
Esterified Estrogens and Methyltestosterone	Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1	TabletOral	Bryant Ranch Prepack	63629-9178	63629-9178-01
Esterified Estrogens and Methyltestosterone	Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1	TabletOral	ECI Pharmaceuticals LLC	51293-639	51293-0639-01
Esterified Estrogens and Methyltestosterone	Estrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1	TabletOral	ECI Pharmaceuticals LLC	51293-640	51293-0640-01
Esterified Estrogens and Methyltestosterone	Estrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1	TabletOral	Bryant Ranch Prepack	72162-1747	72162-1747-01

All 18 Esterified Estrogens and Methyltestosterone NDCs