Over-the-counter drug · ANDA
Julie (Levonorgestrel) NDC 82791-335
Levonorgestrel 1.5 mg/1 · Tablet · Oral · Julie Products Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82791-335-01 | 8279103350182791033501 | 1 BLISTER PACK in 1 BOX, UNIT-DOSE (82791-335-01) / 1 TABLET in 1 BLISTER PACKMarketed from Feb 20, 2025 |
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 IncNDC labeler code 82791
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207660
- Marketing start
- Listing expires
- Other FDA classes
- Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 82791-335_39e7b0c3-ed20-4007-e063-6394a90abbc1SPL ID 39e7b0c3-ed20-4007-e063-6394a90abbc1SPL set ID 2e9784da-2186-a630-e063-6294a90a8493RxCUI 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
N482791033501followed by a unit qualifier and the quantityPackage 82791-0335-01. 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 82791-335
- What is NDC 82791-335?
- 82791-335 is the product NDC for Julie (levonorgestrel), Levonorgestrel 1.5 mg/1 tablet, listed with the FDA by Julie Products Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Julie (Levonorgestrel).
- What is the active ingredient?
- Levonorgestrel.
- Who is the labeler?
- Julie Products Inc, NDC labeler code 82791. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Julie?
- 2 other product NDCs are listed under this name. See all Julie NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Julie products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Julielevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Julie Products Inc. | 82791-532 | 82791-0532-01 |
| Julielevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Julie Products Inc. | 82791-538 | 82791-0538-01 |
Other NDCs under ANDA 207660
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 | Naari Pte Limited | 79929-016 |
| Morning After Pilllevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Cadence Health Inc | 73436-8292 |
| My After Planlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | OHM LABORATORIES INC | 51660-098 |
| My Choicelevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | OHM LABORATORIES INC | 51660-096 |
| Restartlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Winx Health Inc. | 80584-103 |