Over-the-counter drug · ANDA
My Way (Levonorgestrel) NDC 68180-852
Levonorgestrel 1.5 mg/1 · Tablet · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-852-11 | 6818008521168180085211 | 1 BLISTER PACK in 1 CARTON (68180-852-11) / 1 TABLET in 1 BLISTER PACKMarketed from Apr 25, 2017 |
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 68180
- 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 68180-852_910d4acc-07e9-487c-9f5a-385d79ba494aSPL ID 910d4acc-07e9-487c-9f5a-385d79ba494aSPL set ID 3efec61d-e0a6-49c5-9b88-834db6d171fdRxCUI 483325, 1426881UNII 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
N468180085211followed by a unit qualifier and the quantityPackage 68180-0852-11. 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 68180-852
- What is NDC 68180-852?
- 68180-852 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 68180. 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 | Proficient Rx LP | 71205-361 | 71205-0361-01 |
| 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 | Proficient Rx LP | 71205-361 |