Lo-Zumandimine NDC 59651-029

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-029Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0029Add 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
59651-029-87	59651002987	1 POUCH in 1 CARTON (59651-029-87) / 1 BLISTER PACK in 1 POUCH (59651-029-28) / 1 KIT in 1 BLISTER PACKMarketed from Feb 27, 2018
59651-029-88	59651002988	3 POUCH in 1 CARTON (59651-029-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Feb 27, 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): Lo-Zumandimine
Generic name (nonproprietary): drospirenone and ethinyl estradiol
Dosage form: Kit
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209632
Marketing start: Feb 27, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 59651-029_7bc1835a-cc34-4b65-a6b5-f290aee806b4SPL ID 7bc1835a-cc34-4b65-a6b5-f290aee806b4SPL set ID a8c718cc-e235-4710-a9e6-6c58433f3028RxCUI 630734, 748797, 748798, 2003375UPC 0359651029886

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

N459651002987 followed by a unit qualifier and the quantity

Package 59651-0029-87. 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 9, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Lo-Zumandimine is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: Prevent pregnancy. ( 1.1 ) Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. ( 1.2 ) Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. ( 1.3 ) 1.1 Oral Contraceptive Lo-Zumandimine TM is indicated for use by females of reproductive potential to prevent pregnancy. 1.2 Premenstrual Dysphoric Disorder (PMDD) Lo-Zumandimine is also indicated for the treatment of symptom…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209632

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

FDA NDC Directory listings under ANDA 209632
Product	Strength	Form · route	Labeler	Product NDC
Jasmieldrospirenone and ethinyl estradiol	—	Kit	Afaxys Pharma, LLC	50102-240
Drospirenone and Ethinyl Estradiol	—	Kit	NorthStar Rx LLC	72603-875