Over-the-counter drug · ANDA
EContra One-Step (Levonorgestrel) NDC 50102-211
Levonorgestrel 1.5 mg/1 · Tablet · Oral · Afaxys Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50102-211-13 | 5010202111350102021113 | 3 CARTON in 1 PACKAGE (50102-211-13) / 1 BLISTER PACK in 1 CARTON (50102-211-11) / 1 TABLET in 1 BLISTER PACK (50102-211-01)Marketed from Oct 27, 2020 |
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)
- EContra One-Step
- Generic name (nonproprietary)
- levonorgestrel
- Active ingredients
- Levonorgestrel — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Afaxys Pharma, LLCNDC labeler code 50102
- 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 50102-211_d56023fd-6224-4727-bf3e-e5827dfe5f0aSPL ID d56023fd-6224-4727-bf3e-e5827dfe5f0aSPL set ID 94b23c49-dfba-4a70-ada5-e5c212e703c5RxCUI 483325, 1600602UNII 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
N450102021113followed by a unit qualifier and the quantityPackage 50102-0211-13. 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 50102-211
- What is NDC 50102-211?
- 50102-211 is the product NDC for EContra One-Step (levonorgestrel), Levonorgestrel 1.5 mg/1 tablet, listed with the FDA by Afaxys Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- EContra One-Step (Levonorgestrel).
- What is the active ingredient?
- Levonorgestrel.
- Who is the labeler?
- Afaxys Pharma, LLC, NDC labeler code 50102. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for EContra One-Step?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
| 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 | Rugby Laboratories | 0536-1433 |
| 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 |