NDC codes

FDA NDC Directory
Product NDC (as listed)59651-030Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0030Add 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
59651-030-28596510030281 BLISTER PACK in 1 CARTON (59651-030-28) / 1 KIT in 1 BLISTER PACKMarketed from Mar 26, 2018
59651-030-85596510030853 BLISTER PACK in 1 CARTON (59651-030-85) / 1 KIT in 1 BLISTER PACKMarketed from Mar 26, 2018
59651-030-87596510030871 POUCH in 1 CARTON (59651-030-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Mar 26, 2018
59651-030-88596510030883 POUCH in 1 CARTON (59651-030-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Mar 26, 2018

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)
Zumandimine
Generic name (nonproprietary)
drospirenone and ethinyl estradiol
Dosage form
Kit
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209407
Marketing start
Listing expires
Identifiers
Product ID 59651-030_7cec3990-8d5f-4585-8bbc-fe2556cf69f5SPL ID 7cec3990-8d5f-4585-8bbc-fe2556cf69f5SPL set ID 192ad3b0-9ef2-409d-a851-77712202c45aRxCUI 284207, 748797, 748800, 2045196

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

N459651003028 followed by a unit qualifier and the quantity

Package 59651-0030-28. 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)

Zumandimine ® (drospirenone and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy. Zumandimine (drospirenone and ethinyl estradiol tablets) is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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