Over-the-counter drug · ANDA
Levonorgestrel NDC 70700-164
Levonorgestrel 1.5 mg/1 · Tablet · Oral · Xiromed LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-164-06 | 7070001640670700016406 | 1 BLISTER PACK in 1 CARTON (70700-164-06) / 1 TABLET in 1 BLISTER PACKMarketed from Mar 13, 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)
- Levonorgestrel
- Generic name (nonproprietary)
- levonorgestrel
- Active ingredients
- Levonorgestrel — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Xiromed LLCNDC labeler code 70700
- 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 70700-164_6ccbcf9e-fe8a-a97f-06f9-a4e4726d919cSPL ID 6ccbcf9e-fe8a-a97f-06f9-a4e4726d919cSPL set ID 626a2333-ff56-ef28-a287-b33bacc0302aRxCUI 483325UNII 5W7SIA7YZWUPC 0370700164068
- 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
N470700016406followed by a unit qualifier and the quantityPackage 70700-0164-06. 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 70700-164
- What is NDC 70700-164?
- 70700-164 is the product NDC for Levonorgestrel, Levonorgestrel 1.5 mg/1 tablet, listed with the FDA by Xiromed LLC. 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?
- Xiromed LLC, NDC labeler code 70700. 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 | Rugby Laboratories | 0536-1433 | 00536-1433-63 |
| 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 | 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 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 |
|---|---|---|---|---|
| Morning Afterlevonorgestrel | Levonorgestrel 1.5 mg/1.5mg | TabletOral | Rapha Pharmaceuticals, Inc. | 69953-516 |
| 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 |