NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2181Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2181Add 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 NDC11-digit (billing)PackageCopy
71335-2181-1713352181017133521810130 TABLET in 1 BOTTLE (71335-2181-1)Marketed from Oct 25, 2022
71335-2181-27133521810271335218102100 TABLET in 1 BOTTLE (71335-2181-2)Marketed from Oct 25, 2022
71335-2181-3713352181037133521810315 TABLET in 1 BOTTLE (71335-2181-3)Marketed from Oct 25, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 072423
Marketing start
Listing expires
Other FDA classes
Progesterone Congeners (Chemical structure)
Identifiers
Product ID 71335-2181_c46a0f6c-4c7e-4278-81c7-4439cdbaec1fSPL ID c46a0f6c-4c7e-4278-81c7-4439cdbaec1fSPL set ID dd6617df-0876-4fc5-8435-b53d29ccc1aeRxCUI 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

N471335218101 followed by a unit qualifier and the quantity

Package 71335-2181-01. 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 .

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)

About NDC 71335-2181

What is NDC 71335-2181?
71335-2181 is the product NDC for Megestrol Acetate, Megestrol acetate 40 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 3 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Megestrol AcetateMegestrol acetate 20 mg/1TabletOralREMEDYREPACK INC.70518-464070518-4640-00
Megestrol AcetateMegestrol acetate 40 mg/mLSuspensionOralAmerican Health Packaging60687-91660687-0916-0860687-0916-56
Megestrol AcetateMegestrol acetate 400 mg/10mLSuspensionOralMajor Pharmaceuticals0904-757700904-7577-1800904-7577-72
Megestrol AcetateMegestrol acetate 400 mg/10mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-103800121-1038-0000121-1038-40
Megestrol AcetateMegestrol acetate 40 mg/mLSuspensionOralKesin Pharma Corporation81033-15081033-0150-4381033-0150-4481033-0150-52
Megestrol AcetateMegestrol acetate 40 mg/mLSuspensionOralXttrium Laboratories, Inc.0116-401100116-4011-0800116-4011-1100116-4011-16+2 more
Megestrol AcetateMegestrol acetate 40 mg/mLSuspensionOralPreferred Pharmaceuticals Inc.68788-871468788-8714-02
Megestrol AcetateMegestrol acetate 40 mg/mLSuspensionOralANI Pharmaceuticals, Inc.70954-89670954-0896-1070954-0896-20
Megestrol AcetateMegestrol acetate 40 mg/mLSuspensionOralNatco Pharma USA LLC69339-16069339-0160-1669339-0160-1769339-0160-18+1 more
Megestrol AcetateMegestrol acetate 40 mg/mLSuspensionOralPrecision Dose Inc.68094-06368094-0063-6168094-0063-62

All 24 Megestrol Acetate NDCs

Other NDCs under ANDA 072423

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

FDA NDC Directory listings under ANDA 072423
ProductStrengthForm · routeLabelerProduct NDC
Megestrol AcetateMegestrol acetate 40 mg/1TabletOralMajor Pharmaceuticals0904-7236
Megestrol AcetateMegestrol acetate 40 mg/1TabletOralStrides Pharma Science Limited64380-159

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