NDC codes

FDA NDC Directory
Product NDC (as listed)43393-001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43393-0001Add 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
43393-001-0643393000106433930001066 CARTON in 1 PACKAGE (43393-001-06) / 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (43393-001-01)Marketed from May 1, 2019

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)
Mifepristone
Generic name (nonproprietary)
mifepristone
Active ingredients
Mifepristone — 200 mg/1
Dosage form
Tablet
Route
Oral
Labeler
GenBioPro, Inc.NDC labeler code 43393
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091178
Marketing start
Listing expires
Other FDA classes
Progestational Hormone Receptor Antagonists (Mechanism)
Identifiers
Product ID 43393-001_539725c1-189c-1934-e063-6294a90ac3c0SPL ID 539725c1-189c-1934-e063-6294a90ac3c0SPL set ID b63fad9b-7f12-4400-9019-b0586054e534RxCUI 311704UNII 320T6RNW1FUPC 0343393001019
Pharmacologic class
Progestin Antagonist

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

N443393000106 followed by a unit qualifier and the quantity

Package 43393-0001-06. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Mifepristone tablets, 200 mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. Mifepristone tablets, 200 mg is a progestin antagonist indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43393-001

What is NDC 43393-001?
43393-001 is the product NDC for Mifepristone, Mifepristone 200 mg/1 tablet, listed with the FDA by GenBioPro, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Mifepristone.
What is the active ingredient?
Mifepristone.
Who is the labeler?
GenBioPro, Inc., NDC labeler code 43393. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mifepristone?
3 other product NDCs are listed under this name. See all Mifepristone 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 Mifepristone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MifepristoneMifepristone 200 mg/1TabletOralEvita Solutions LLC84670-01484670-0014-01
MifepristoneMifepristone 300 mg/1TabletOralCorcept Therapeutics Incorporated76346-65476346-0654-03
MifepristoneMifepristone 300 mg/1Tablet, Film coatedOralActavis Pharma, Inc.0591-439000591-4390-96

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in