Over-the-counter drug · ANDA
Julie (levonorgestrel) NDC 82791-538
Levonorgestrel 1.5 mg/1 · Tablet · Oral · Julie Products Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82791-538-01 | 82791053801 | 1 BLISTER PACK in 1 CARTON (82791-538-01) / 1 TABLET in 1 BLISTER PACKMarketed from Jul 15, 2022 |
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)
- Julie
- Generic name (nonproprietary)
- levonorgestrel
- Active ingredients
- Levonorgestrel — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Julie Products Inc.
- 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 82791-538_5ea0818f-2238-4f12-b58a-4bed37ef798bSPL ID 5ea0818f-2238-4f12-b58a-4bed37ef798bSPL set ID 8fb303ec-3b6a-47ac-9ad9-83ab6f0d6ae8RxCUI 483325, 2606549UNII 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
N482791053801followed by a unit qualifier and the quantityPackage 82791-0538-01. 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.
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 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Rugby Laboratories | 0536-1433 |
| 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 |
| 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 |