Over-the-counter drug · ANDA
My Way (Levonorgestrel) NDC 43386-622
Levonorgestrel 1.5 mg/1 · Tablet · Oral · Lupin Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43386-622-30 | 43386062230 | 1 TABLET in 1 CARTON (43386-622-30)Marketed from Feb 15, 2013 |
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
- Lupin Pharmaceuticals,Inc.NDC labeler code 43386
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202508
- Marketing start
- Listing expires
- Other FDA classes
- Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 43386-622_6dce7821-019c-4344-9634-5a51060920d5SPL ID 6dce7821-019c-4344-9634-5a51060920d5SPL set ID ec01077e-ac3c-424a-9edc-0854fe0a2e0dRxCUI 483325, 1426881UNII 5W7SIA7YZW
- Pharmacologic class
- Progestin; Progestin-containing Intrauterine Device
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
N443386062230followed by a unit qualifier and the quantityPackage 43386-0622-30. 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 43386-622
- What is NDC 43386-622?
- 43386-622 is the product NDC for My Way (levonorgestrel), Levonorgestrel 1.5 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals,Inc.. 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?
- Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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 | Proficient Rx LP | 71205-361 | 71205-0361-01 |
Other NDCs under ANDA 202508
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 |
|---|---|---|---|---|
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Novel Laboratories, Inc. | 40032-622 |