Prescription drug · ANDA
Nikki NDC 68180-886
drospirenone and ethinyl estradiol · Kit · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-886-73 | 68180088673 | 3 BLISTER PACK in 1 CARTON (68180-886-73) / 1 KIT in 1 BLISTER PACKMarketed from Nov 30, 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)
- Nikki
- Generic name (nonproprietary)
- drospirenone and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201661
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-886_d5033102-e177-4057-bf0d-d7df320d59e9SPL ID d5033102-e177-4057-bf0d-d7df320d59e9SPL set ID 9aff6034-044c-466d-bf52-18a998d47f66RxCUI 630734, 748797, 748798, 1543553UPC 0368180886716
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
N468180088673followed by a unit qualifier and the quantityPackage 68180-0886-73. 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)
Nikki (drospirenone and ethinyl estradiol tablets USP) 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 Nikki™ (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg is indicated for use by females of reproductive potential to prevent pregnancy. 1.2 Premenst…
Excerpt only. Read the full label for complete information.