Over-the-counter drug · ANDA
Morning After (Levonorgestrel) NDC 69953-516
Levonorgestrel 1.5 mg/1.5mg · Tablet · Oral · Rapha Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69953-516-01 | 6995305160169953051601 | 1 BLISTER PACK in 1 CARTON (69953-516-01) / 1 mg in 1 BLISTER PACKMarketed from Jan 16, 2023 |
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)
- Morning After
- Generic name (nonproprietary)
- levonorgestrel
- Active ingredients
- Levonorgestrel — 1.5 mg/1.5mg
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rapha Pharmaceuticals, Inc.NDC labeler code 69953
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205329
- Marketing start
- Listing expires
- Other FDA classes
- Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 69953-516_f0fabe80-87bc-9b65-e053-2995a90a582bSPL ID f0fabe80-87bc-9b65-e053-2995a90a582bSPL set ID f0fab784-3d28-35fb-e053-2995a90ab611RxCUI 483325, 1657617UNII 5W7SIA7YZW
- Pharmacologic class
- Progestin; Progestin-containing Intrauterine Device
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
N469953051601followed by a unit qualifier and the quantityPackage 69953-0516-01. 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 69953-516
- What is NDC 69953-516?
- 69953-516 is the product NDC for Morning After (levonorgestrel), Levonorgestrel 1.5 mg/1.5mg tablet, listed with the FDA by Rapha Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Morning After (Levonorgestrel).
- What is the active ingredient?
- Levonorgestrel.
- Who is the labeler?
- Rapha Pharmaceuticals, Inc., NDC labeler code 69953. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Morning After?
- 2 other product NDCs are listed under this name. See all Morning After NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Morning After products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Morning Afterlevonorgestrel | Levonorgestrel 1.5 mg/1.5mg | TabletOral | Rapha Pharmaceuticals, Inc. | 69953-517 | 69953-0517-01 |
| Morning Afterlevonorgestrel | Levonorgestrel 1.5 mg/1.5mg | TabletOral | Rapha Pharmaceuticals, Inc. | 69953-515 | 69953-0515-01 |
Other NDCs under ANDA 205329
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 | Xiromed LLC | 70700-164 |
| Morning Afterlevonorgestrel | Levonorgestrel 1.5 mg/1.5mg | TabletOral | Rapha Pharmaceuticals, Inc. | 69953-517 |
| PostDay One-Steplevonorgestrel | Levonorgestrel 1.5 mg/1.5mg | TabletOral | Rapha Pharmaceuticals, Inc. | 69953-617 |
| PostDay One-Steplevonorgestrel | Levonorgestrel 1.5 mg/1.5mg | TabletOral | Rapha Pharmaceuticals, Inc. | 69953-618 |
| PostDay One-Steplevonorgestrel | Levonorgestrel 1.5 mg/1.5mg | TabletOral | Rapha Pharmaceuticals, Inc. | 69953-628 |