Over-the-counter drug · ANDA
Her Style (Levonorgestrel) NDC 50742-352
Levonorgestrel 1.5 mg/1 · Tablet · Oral · Ingenus Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-352-01 | 5074203520150742035201 | 1 BLISTER PACK in 1 CARTON (50742-352-01) / 1 TABLET in 1 BLISTER PACKMarketed from Nov 30, 2022 |
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)
- Her Style
- Generic name (nonproprietary)
- levonorgestrel
- Active ingredients
- Levonorgestrel — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Ingenus Pharmaceuticals, LLCNDC labeler code 50742
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207976
- Marketing start
- Listing expires
- Other FDA classes
- Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 50742-352_9ebc666c-47b1-477a-a9e0-8a761b809cccSPL ID 9ebc666c-47b1-477a-a9e0-8a761b809cccSPL set ID 6e631755-b7c5-4a3a-b46d-f66b4ceedb1cRxCUI 483325, 1855519UNII 5W7SIA7YZW
- Pharmacologic class
- Progestin; Progestin-containing Intrauterine System
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450742035201followed by a unit qualifier and the quantityPackage 50742-0352-01. 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 .
Indications (excerpt from the label)
USE Use for women to reduce the chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)
Excerpt only. Read the full label for complete information.
About NDC 50742-352
- What is NDC 50742-352?
- 50742-352 is the product NDC for Her Style (levonorgestrel), Levonorgestrel 1.5 mg/1 tablet, listed with the FDA by Ingenus Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Her Style (Levonorgestrel).
- What is the active ingredient?
- Levonorgestrel.
- Who is the labeler?
- Ingenus Pharmaceuticals, LLC, NDC labeler code 50742. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Her Style?
- 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 207976
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 |
|---|---|---|---|---|
| New Daylevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Northstar Rx LLC | 16714-809 |