What is NDC 0116-4011?

0116-4011 is the product NDC for Megestrol Acetate, Megestrol acetate 40 mg/mL suspension, listed with the FDA by Xttrium Laboratories, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.

Xttrium Laboratories, Inc., NDC labeler code 0116. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Megestrol Acetate?

23 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Megestrol Acetate NDC 0116-4011 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0116-4011Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00116-4011Add 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
0116-4011-08	0011640110800116401108	237 mL in 1 BOTTLE, PLASTIC (0116-4011-08)Marketed from Mar 28, 2025
0116-4011-11	0011640111100116401111	10 TRAY in 1 CASE (0116-4011-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10)Marketed from Mar 28, 2025
0116-4011-16	0011640111600116401116	480 mL in 1 BOTTLE, PLASTIC (0116-4011-16)Marketed from Mar 28, 2025
0116-4011-30	0011640113000116401130	30 TRAY in 1 CASE (0116-4011-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10)Marketed from Mar 28, 2025
0116-4011-40	0011640114000116401140	40 TRAY in 1 CASE (0116-4011-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10)Marketed from Mar 28, 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 — 40 mg/mL
Dosage form: Suspension
Route: Oral
Labeler: Xttrium Laboratories, Inc.NDC labeler code 0116
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076721
Marketing start: Mar 28, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Progesterone Congeners (Chemical structure)
Identifiers: Product ID 0116-4011_3aae2aec-a959-8e66-e063-6294a90a8f46SPL ID 3aae2aec-a959-8e66-e063-6294a90a8f46SPL set ID 3169f883-4076-32ce-e063-6394a90a4925RxCUI 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

N400116401108 followed by a unit qualifier and the quantity

Package 00116-4011-08. 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 Jul 24, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Megestrol Acetate Oral Suspension, USP 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)

About NDC 0116-4011

What is NDC 0116-4011?: 0116-4011 is the product NDC for Megestrol Acetate, Megestrol acetate 40 mg/mL suspension, listed with the FDA by Xttrium Laboratories, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Megestrol Acetate.
What is the active ingredient?: Megestrol acetate.
Who is the labeler?: Xttrium Laboratories, Inc., NDC labeler code 0116. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Megestrol Acetate?: 23 other product NDCs are listed under this name. See all Megestrol Acetate 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 Megestrol Acetate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Megestrol Acetate	Megestrol acetate 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-4640	70518-4640-00
Megestrol Acetate	Megestrol acetate 40 mg/mL	SuspensionOral	American Health Packaging	60687-916	60687-0916-0860687-0916-56
Megestrol Acetate	Megestrol acetate 400 mg/10mL	SuspensionOral	Major Pharmaceuticals	0904-7577	00904-7577-1800904-7577-72
Megestrol Acetate	Megestrol acetate 400 mg/10mL	SuspensionOral	PAI Holdings, LLC dba PAI Pharma	0121-1038	00121-1038-0000121-1038-40
Megestrol Acetate	Megestrol acetate 40 mg/mL	SuspensionOral	Kesin Pharma Corporation	81033-150	81033-0150-4381033-0150-4481033-0150-52
Megestrol Acetate	Megestrol acetate 40 mg/mL	SuspensionOral	Preferred Pharmaceuticals Inc.	68788-8714	68788-8714-02
Megestrol Acetate	Megestrol acetate 40 mg/mL	SuspensionOral	ANI Pharmaceuticals, Inc.	70954-896	70954-0896-1070954-0896-20
Megestrol Acetate	Megestrol acetate 40 mg/mL	SuspensionOral	Natco Pharma USA LLC	69339-160	69339-0160-1669339-0160-1769339-0160-18+1 more
Megestrol Acetate	Megestrol acetate 40 mg/mL	SuspensionOral	Precision Dose Inc.	68094-063	68094-0063-6168094-0063-62
Megestrol Acetate	Megestrol acetate 40 mg/mL	SuspensionOral	Precision Dose Inc.	68094-174	68094-0174-62

All 24 Megestrol Acetate NDCs