Over-the-counter drug · ANDA
Opcicon One-Step (levonorgestrel) NDC 62756-718
Levonorgestrel 1.5 mg/1 · Tablet · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62756-718-60 | 62756071860 | 1 BLISTER PACK in 1 CARTON (62756-718-60) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 12, 2014 |
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)
- Opcicon One-Step
- Generic name (nonproprietary)
- levonorgestrel
- Active ingredients
- Levonorgestrel — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202635
- Marketing start
- Listing expires
- Other FDA classes
- Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 62756-718_61d03fd1-1f93-4f6c-940c-e436ab1b63a9SPL ID 61d03fd1-1f93-4f6c-940c-e436ab1b63a9SPL set ID b67ca313-561e-471f-baf3-257b7e253c75RxCUI 483325, 1549091UNII 5W7SIA7YZWUPC 0362756718609
- 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
N462756071860followed by a unit qualifier and the quantityPackage 62756-0718-60. 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 for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use bir th control)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202635
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 | Ohm Laboratories Inc. | 51660-723 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Ohm Laboratories Inc. | 51660-999 |
| LEADER Emergency Contraceptive Levonorgestrellevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Cardinal Health 110, LLC. DBA Leader | 70000-0600 |
| My Choice TMlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Proficient Rx LP | 71205-120 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Thirty Madison Inc. | 71713-098 |
| My Choice TMlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | SUN PHARMACEUTICAL INDUSTRIES, INC. | 62756-720 |
| AfterPlanlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | SUN PHARMACEUTICAL INDUSTRIES, INC. | 62756-723 |