Megestrol Acetate NDC 64380-158

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-158Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0158Add 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
64380-158-01	64380015801	100 TABLET in 1 BOTTLE (64380-158-01)Marketed from Apr 11, 2022

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): Megestrol Acetate
Generic name (nonproprietary): megestrol acetate
Active ingredients: Megestrol acetate — 20 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Strides Pharma Science Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 072422
Marketing start: Apr 11, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Progesterone Congeners (Chemical structure)
Identifiers: Product ID 64380-158_0eff5604-5d6a-4e95-9a10-db18fb8046b6SPL ID 0eff5604-5d6a-4e95-9a10-db18fb8046b6SPL set ID 8ec70070-da70-4a38-9d58-cf2278517661RxCUI 860215, 860221UNII TJ2M0FR8ES
Pharmacologic class: Progestin

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

N464380015801 followed by a unit qualifier and the quantity

Package 64380-0158-01. 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 Feb 24, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 072422

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 072422
Product	Strength	Form · route	Labeler	Product NDC
Megestrol Acetate	Megestrol acetate 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-4640