Prescription drug · ANDA
Jasmiel (Drospirenone and ethinyl estradiol) NDC 50102-240
Kit · Afaxys Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50102-240-23 | 5010202402350102024023 | 3 POUCH in 1 CARTON (50102-240-23) / 1 BLISTER PACK in 1 POUCH (50102-240-21) / 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)
- Jasmiel
- Generic name (nonproprietary)
- drospirenone and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Afaxys Pharma, LLCNDC labeler code 50102
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209632
- Marketing start
- Listing expires
- Identifiers
- Product ID 50102-240_0aa4242b-bc9f-4bb5-8fc1-a286216706b7SPL ID 0aa4242b-bc9f-4bb5-8fc1-a286216706b7SPL set ID 1a3211f8-41f5-4905-a466-0d79add5fdadRxCUI 630734, 748797, 748798, 2106997
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
N450102024023followed by a unit qualifier and the quantityPackage 50102-0240-23. 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)
Jasmiel 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 Jasmiel ® is indicated for use by females of reproductive potential to prevent pregnancy. 1.2 Premenstrual Dysphoric Disorder (PMDD) Jasmiel is also indicated for the treatment of symptoms of premenstrual dysp…
Excerpt only. Read the full label for complete information.
About NDC 50102-240
- What is NDC 50102-240?
- 50102-240 is the product NDC for Jasmiel kit, listed with the FDA by Afaxys Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Jasmiel (Drospirenone and Ethinyl Estradiol).
- Who is the labeler?
- Afaxys Pharma, LLC, NDC labeler code 50102. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Jasmiel?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
|---|---|---|---|---|
| Drospirenone and Ethinyl Estradiol | — | Kit | NorthStar Rx LLC | 72603-875 |
| Lo-Zumandiminedrospirenone and ethinyl estradiol | — | Kit | Aurobindo Pharma Limited | 59651-029 |