Prepidil (dinoprostone) NDC 0009-3359

NDC codes

FDA NDC Directory

Product NDC (as listed)0009-3359Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00009-3359Add 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
0009-3359-01	00009335901	1 SYRINGE in 1 CARTON (0009-3359-01) / 3 g in 1 SYRINGEMarketed from Dec 11, 2019

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): Prepidil
Generic name (nonproprietary): dinoprostone
Active ingredients: Dinoprostone — .5 mg/3g
Dosage form: Gel
Route: Vaginal
Labeler: Pharmacia & Upjohn Company LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019617
Marketing start: Dec 9, 1992
Listing expires: Dec 31, 2026
Other FDA classes: Prostaglandins (Chemical structure)
Identifiers: Product ID 0009-3359_e72f678f-ff11-47d7-94ea-186113ec3fbdSPL ID e72f678f-ff11-47d7-94ea-186113ec3fbdSPL set ID ab03de5b-782c-4f81-a8dc-7ef9969dd0cfRxCUI 208397, 309922UNII K7Q1JQR04MUPC 0300093359024
Pharmacologic class: Prostaglandin Analog

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400009335901 followed by a unit qualifier and the quantity

Package 00009-3359-01. 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 Oct 22, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE PREPIDIL Gel is indicated for ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)