Over-the-counter drug · ANDA
LEADER Emergency Contraceptive Levonorgestrel (Levonorgestrel) NDC 70000-0600
Levonorgestrel 1.5 mg/1 · Tablet · Oral · Cardinal Health 110, LLC. DBA Leader
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0600-1 | 7000006000170000060001 | 1 BLISTER PACK in 1 CARTON (70000-0600-1) / 1 TABLET in 1 BLISTER PACKMarketed from Mar 22, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- LEADER Emergency Contraceptive Levonorgestrel
- Generic name (nonproprietary)
- levonorgestrel
- Active ingredients
- Levonorgestrel — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cardinal Health 110, LLC. DBA LeaderNDC labeler code 70000
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202635
- Marketing start
- Marketing end
- Other FDA classes
- Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 70000-0600_51245457-71af-6325-e063-6394a90ade8bSPL ID 51245457-71af-6325-e063-6394a90ade8bSPL set ID d1e33615-0a98-4223-833d-843c758d9db7RxCUI 483325UNII 5W7SIA7YZWUPC 0096295141924
- 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
N470000060001followed by a unit qualifier and the quantityPackage 70000-0600-01. 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 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 70000-0600
- What is NDC 70000-0600?
- 70000-0600 is the product NDC for LEADER Emergency Contraceptive Levonorgestrel, Levonorgestrel 1.5 mg/1 tablet, listed with the FDA by Cardinal Health 110, LLC. DBA Leader. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- LEADER Emergency Contraceptive Levonorgestrel (Levonorgestrel).
- What is the active ingredient?
- Levonorgestrel.
- Who is the labeler?
- Cardinal Health 110, LLC. DBA Leader, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for LEADER Emergency Contraceptive Levonorgestrel?
- 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 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 |
|---|---|---|---|---|
| AfterPlanlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | SUN PHARMACEUTICAL INDUSTRIES, INC. | 62756-723 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Ohm Laboratories Inc. | 51660-723 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Ohm Laboratories Inc. | 51660-999 |
| 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 |
| My Choice TMlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Proficient Rx LP | 71205-120 |
| Opcicon One-Steplevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 62756-718 |