Prescription drug · ANDA
Larin 1/20 (Norethindrone acetate/ethinyl estradiol) NDC 16714-408
Kit · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-408-01 | 1671404080116714040801 | 1 BLISTER PACK in 1 PACKET (16714-408-01) / 1 KIT in 1 BLISTER PACKMarketed from Dec 4, 2013 | |
| 16714-408-02 | 1671404080216714040802 | 1 BLISTER PACK in 1 CARTON (16714-408-02) / 1 KIT in 1 BLISTER PACKMarketed from Dec 4, 2013 | |
| 16714-408-03 | 1671404080316714040803 | 3 BLISTER PACK in 1 CARTON (16714-408-03) / 1 KIT in 1 BLISTER PACKMarketed from Dec 4, 2013 | |
| 16714-408-04 | 1671404080416714040804 | 6 BLISTER PACK in 1 CARTON (16714-408-04) / 1 KIT in 1 BLISTER PACKMarketed from Dec 4, 2013 |
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)
- Larin 1/20
- Generic name (nonproprietary)
- norethindrone acetate/ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Northstar Rx LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202995
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-408_98de80bb-4d53-4caa-9613-b1acf0fa9d0eSPL ID 98de80bb-4d53-4caa-9613-b1acf0fa9d0eSPL set ID b6985be4-86b4-41ad-bd4d-a5d25c77062aRxCUI 1358762, 1358776, 1487086
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N416714040801followed by a unit qualifier and the quantityPackage 16714-0408-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE LARIN™ 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I
Excerpt only. Read the full label for complete information.
About NDC 16714-408
- What is NDC 16714-408?
- 16714-408 is the product NDC for Larin 1/20 (norethindrone acetate/ethinyl estradiol) kit, listed with the FDA by Northstar Rx LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Larin 1/20 (Norethindrone Acetate/Ethinyl Estradiol).
- Who is the labeler?
- Northstar Rx LLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Larin 1/20?
- 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 202995
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 |
|---|---|---|---|---|
| Microgestin 1/20norethindrone acetate/ethinyl estradiol | — | Kit | Mayne Pharma Inc. | 51862-868 |
| Microgestin 1/20norethindrone acetate/ethinyl estradiol | — | Kit | Dr.Reddy's Laboratories Inc. | 75907-084 |