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 | 0053614336300536143363 | 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 LaboratoriesNDC labeler code 0536
- 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
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 0536-1433
- What is NDC 0536-1433?
- 0536-1433 is the product NDC for Levonorgestrel, Levonorgestrel 1.5 mg/1 tablet, listed with the FDA by Rugby Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levonorgestrel.
- What is the active ingredient?
- Levonorgestrel.
- Who is the labeler?
- Rugby Laboratories, NDC labeler code 0536. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Levonorgestrel?
- 11 other product NDCs are listed under this name. See all Levonorgestrel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Levonorgestrel products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | YYBA CORP | 73581-017 | 73581-0017-01 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | YYBA Corp | 73581-217 | 73581-0217-01 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Camber Consumer Care Inc | 69230-333 | 69230-0333-3269230-0333-3369230-0333-34 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Thirty Madison Inc. | 71713-098 | 71713-0098-11 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | LEADER/ CARDINAL HEALTH 110, INC. | 70000-0675 | 70000-0675-01 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Naari Pte Limited | 79929-016 | 79929-0016-01 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | GLENMARK THERAPEUTICS INC., USA | 72657-123 | 72657-0123-11 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Xiromed LLC | 70700-164 | 70700-0164-06 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Ohm Laboratories Inc. | 51660-723 | 51660-0723-11 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Ohm Laboratories Inc. | 51660-999 | 51660-0999-0151660-0999-11 |
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 |
|---|---|---|---|---|
| After Bangerlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Aurohealth LLC | 58602-891 |
| Amazon Basic Care Levonorgestrellevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Amazon.com Services LLC | 72288-324 |
| Athentia Nextlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Aurohealth LLC | 58602-721 |
| Econ Morning Afterlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Aurohealth LLC | 58602-841 |
| EContra One-Steplevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Afaxys Pharma, LLC | 50102-211 |
| Fem Choice morning afterlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Aurohealth LLC | 58602-712 |
| Ithappenz Morning Afterlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Aurohealth LLC | 58602-892 |
| Julielevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Julie Products Inc. | 82791-532 |
| Julielevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Julie Products Inc. | 82791-538 |
| 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 |
| Julie Morning After Pilllevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Julie Products Inc. | 82791-004 |
| Levonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | LEADER/ CARDINAL HEALTH 110, INC. | 70000-0675 |
| Morning Afterlevonorgestrel | Levonorgestrel 1.5 mg/1.5mg | TabletOral | Rapha Pharmaceuticals, Inc. | 69953-515 |