Over-the-counter drug · NDA
Plan B One-Step (levonorgestrel) NDC 50090-5978
Levonorgestrel 1.5 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5978-0 | 50090597800 | 1 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-5978-0) / 1 TABLET in 1 BLISTER PACKMarketed from May 5, 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)
- Plan B One-Step
- Generic name (nonproprietary)
- levonorgestrel
- Active ingredients
- Levonorgestrel — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021998
- Marketing start
- Listing expires
- Other FDA classes
- Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 50090-5978_ed3f7b10-a3ca-45b2-94ae-ba22560450f0SPL ID ed3f7b10-a3ca-45b2-94ae-ba22560450f0SPL set ID fcc7ba8e-ad54-4efe-87e4-5eb0fbf4f064RxCUI 483325, 858079UNII 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
N450090597800followed by a unit qualifier and the quantityPackage 50090-5978-00. 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 NDA 021998
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 |
|---|---|---|---|---|
| Afteralevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Foundation Consumer Healthcare LLC | 69536-103 |
| Next Choice One Doselevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Foundation Consumer Healthcare LLC | 69536-133 |
| Plan B One-Steplevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Foundation Consumer Healthcare LLC | 69536-146 |
| Plan B One-Steplevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Foundation Consumer Healthcare LLC | 69536-162 |
| Take Actionlevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Foundation Consumer Healthcare LLC | 69536-200 |