Over-the-counter drug · ANDA
Levonorgestrel NDC 0536-1433
Levonorgestrel 1.5 mg/1 · Tablet · Oral · Rugby Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1433-63 | 00536143363 | 1 BLISTER PACK in 1 CARTON (0536-1433-63) / 1 TABLET in 1 BLISTER PACKMarketed from May 24, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Levonorgestrel
- Generic name (nonproprietary)
- levonorgestrel
- Active ingredients
- Levonorgestrel — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rugby Laboratories
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206867
- Marketing start
- Listing expires
- Other FDA classes
- Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 0536-1433_3be559d9-2886-4f0a-9c4b-d25e13a98cafSPL ID 3be559d9-2886-4f0a-9c4b-d25e13a98cafSPL set ID 076126e4-9d76-45cd-a86b-5b35c56b620aRxCUI 483325UNII 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
N400536143363followed by a unit qualifier and the quantityPackage 00536-1433-63. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 206867
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 |
|---|---|---|---|---|
| Morning Afterlevonorgestrel | Levonorgestrel 1.5 mg/1.5mg | TabletOral | Rapha Pharmaceuticals, Inc. | 69953-515 |
| Fem Choice morning afterlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Aurohealth LLC | 58602-712 |
| Julie Morning After Pilllevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Julie Products Inc. | 82791-002 |
| Julie Morning After Pilllevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Julie Products Inc. | 82791-003 |
| Athentia Nextlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Aurohealth LLC | 58602-721 |
| Julie Morning After Pilllevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Julie Products Inc. | 82791-004 |
| Julielevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Julie Products Inc. | 82791-532 |
| Julielevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Julie Products Inc. | 82791-538 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | LEADER/ CARDINAL HEALTH 110, INC. | 70000-0675 |
| Amazon Basic Care Levonorgestrellevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Amazon.com Services LLC | 72288-324 |
| EContra One-Steplevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Afaxys Pharma, LLC | 50102-211 |
| Econ Morning Afterlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Aurohealth LLC | 58602-841 |
| Ithappenz Morning Afterlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Aurohealth LLC | 58602-892 |
| After Bangerlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Aurohealth LLC | 58602-891 |