Prescription drug · ANDA
Drospirenone and Ethinyl Estradiol NDC 72603-875
Kit · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-875-03 | 72603087503 | 3 POUCH in 1 CARTON (72603-875-03) / 1 BLISTER PACK in 1 POUCH (72603-875-01) / 1 KIT in 1 BLISTER PACKMarketed from Sep 1, 2025 |
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)
- Drospirenone and Ethinyl Estradiol
- Generic name (nonproprietary)
- drospirenone and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- NorthStar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209632
- Marketing start
- Listing expires
- Identifiers
- Product ID 72603-875_c88c3eb8-3bf5-4004-a7ab-7218cd2f9182SPL ID c88c3eb8-3bf5-4004-a7ab-7218cd2f9182SPL set ID c88c3eb8-3bf5-4004-a7ab-7218cd2f9182RxCUI 630734, 748797, 748798
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
N472603087503followed by a unit qualifier and the quantityPackage 72603-0875-03. 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)
Drospirenone and ethinyl estradiol tablets are 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 Drospirenone and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. 1.2 Premenstrual Dysphoric Disorder (PMDD) Drospi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209632
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Lo-Zumandiminedrospirenone and ethinyl estradiol | — | Kit | Aurobindo Pharma Limited | 59651-029 |
| Jasmieldrospirenone and ethinyl estradiol | — | Kit | Afaxys Pharma, LLC | 50102-240 |