Over-the-counter drug · ANDA
AfterPill (levonorgestrel) NDC 64122-605
Levonorgestrel 1.5 mg/1 · Tablet · Oral · Syzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64122-605-01 | 64122060501 | 1 TABLET in 1 BLISTER PACK (64122-605-01)Marketed from Sep 14, 2017 |
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)
- AfterPill
- Generic name (nonproprietary)
- levonorgestrel
- Active ingredients
- Levonorgestrel — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201446
- Marketing start
- Listing expires
- Other FDA classes
- Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 64122-605_375a97f0-1569-4470-961d-93261430b139SPL ID 375a97f0-1569-4470-961d-93261430b139SPL set ID 4d284ba4-9cd7-48e4-95b9-cd6d0367bfd1RxCUI 483325, 1545303UNII 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
N464122060501followed by a unit qualifier and the quantityPackage 64122-0605-01. 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)
Indications 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 201446
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 |
|---|---|---|---|---|
| My Waylevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4294 |
| My Waylevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Proficient Rx LP | 71205-361 |
| My Waylevonorgestrel | Levonorgestrel 1.5 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-852 |