Over-the-counter drug · ANDA
My Way (Levonorgestrel) NDC 71205-361
Levonorgestrel 1.5 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-361-01 | 7120503610171205036101 | 1 BLISTER PACK in 1 CARTON (71205-361-01) / 1 TABLET in 1 BLISTER PACKMarketed from Nov 18, 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)
- My Way
- Generic name (nonproprietary)
- levonorgestrel
- Active ingredients
- Levonorgestrel — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201446
- Marketing start
- Listing expires
- Other FDA classes
- Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 71205-361_4339bf43-b900-486f-ad48-def5690a2a5cSPL ID 4339bf43-b900-486f-ad48-def5690a2a5cSPL set ID f2354b0c-dda4-4eb4-93f3-b2d57856a948RxCUI 483325, 1426881UNII 5W7SIA7YZWUPC 0371205361013
- 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
N471205036101followed by a unit qualifier and the quantityPackage 71205-0361-01. 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)
Indications Use for women to reduce 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 71205-361
- What is NDC 71205-361?
- 71205-361 is the product NDC for My Way (levonorgestrel), Levonorgestrel 1.5 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- My Way (Levonorgestrel).
- What is the active ingredient?
- Levonorgestrel.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 71205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for My Way?
- 3 other product NDCs are listed under this name. See all My Way NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other My Way products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| My Waylevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4294 | 68071-4294-01 |
| My Waylevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-852 | 68180-0852-11 |
| My Waylevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Lupin Pharmaceuticals,Inc. | 43386-622 | 43386-0622-30 |
Other NDCs under ANDA 201446
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 |
|---|---|---|---|---|
| AfterPilllevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Syzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880 | 64122-605 |
| My Waylevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4294 |
| My Waylevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-852 |