Prescription drug · ANDA
Loryna NDC 70700-114
drospirenone and ethinyl estradiol tablets · Kit · Xiromed, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-114-85 | 7070001148570700011485 | 3 BLISTER PACK in 1 CARTON (70700-114-85) / 1 KIT in 1 BLISTER PACKMarketed from Feb 10, 2023 |
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)
- Loryna
- Generic name (nonproprietary)
- drospirenone and ethinyl estradiol tablets
- Dosage form
- Kit
- Labeler
- Xiromed, LLC.NDC labeler code 70700
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079221
- Marketing start
- Listing expires
- Identifiers
- Product ID 70700-114_7d092d47-a8c8-f64d-8c26-c42aa7fdbdb6SPL ID 7d092d47-a8c8-f64d-8c26-c42aa7fdbdb6SPL set ID da872266-d5f2-35df-096e-341f58d93427RxCUI 630734, 748797, 748798, 1099026
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
N470700011485followed by a unit qualifier and the quantityPackage 70700-0114-85. 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)
Loryna (drospirenone and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to: Prevent pregnancy. ( 1.1 ) Treat symptoms of premenstrual dysphoric disorder (PMDD) for women 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 Loryna (drospirenone and ethinyl estradiol tablets) are indicated for use by women to prevent pregnancy. 1.2 Premenstrual Dysphoric Disorder (PMDD) Loryna is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an…
Excerpt only. Read the full label for complete information.
About NDC 70700-114
- What is NDC 70700-114?
- 70700-114 is the product NDC for Loryna kit, listed with the FDA by Xiromed, LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loryna (Drospirenone and Ethinyl Estradiol Tablets).
- Who is the labeler?
- Xiromed, LLC., NDC labeler code 70700. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Loryna?
- 1 other product NDC are listed under this name. See all Loryna NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Loryna products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lorynadrospirenone and ethinyl estradiol tablets | — | Kit | Bryant Ranch Prepack | 63629-2336 | 63629-2336-01 |
Other NDCs under ANDA 079221
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 |
|---|---|---|---|---|
| Lorynadrospirenone and ethinyl estradiol tablets | — | Kit | Bryant Ranch Prepack | 63629-2336 |