Megestrol Acetate NDC 0121-1038

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-1038Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-1038Add 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
0121-1038-00	00121103800	10 TRAY in 1 CASE (0121-1038-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1038-10)Marketed from Oct 17, 2025
0121-1038-40	00121103840	4 TRAY in 1 CASE (0121-1038-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1038-10)Marketed from Oct 17, 2025

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 400 mg/10mL
Dosage form: Suspension
Route: Oral
Labeler: PAI Holdings, LLC dba PAI Pharma
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077404
Marketing start: Oct 17, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Progesterone Congeners (Chemical structure)
Identifiers: Product ID 0121-1038_5dbcf915-968f-4377-b56f-8ef863e398caSPL ID 5dbcf915-968f-4377-b56f-8ef863e398caSPL set ID 2d5b58cd-cbb1-4f5c-b13f-63185c0f8e31RxCUI 860225UNII 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

N400121103800 followed by a unit qualifier and the quantity

Package 00121-1038-00. 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 Oct 17, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Megestrol acetate oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077404

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

FDA NDC Directory listings under ANDA 077404
Product	Strength	Form · route	Labeler	Product NDC
Megestrol Acetate	Megestrol acetate 40 mg/mL	SuspensionOral	ANI Pharmaceuticals, Inc.	70954-896
Megestrol Acetate	Megestrol acetate 40 mg/mL	SuspensionOral	American Health Packaging	60687-916
Megestrol Acetate	Megestrol acetate 400 mg/10mL	SuspensionOral	Major Pharmaceuticals	0904-7577