Prescription drug · ANDA
Larin 24 Fe NDC 16714-416
norethindrone acetate/ethinyl estradiol and ferrous fumarate · Kit · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-416-01 | 1671404160116714041601 | 1 BLISTER PACK in 1 PACKET (16714-416-01) / 1 KIT in 1 BLISTER PACKMarketed from Feb 18, 2015 | |
| 16714-416-02 | 1671404160216714041602 | 1 BLISTER PACK in 1 CARTON (16714-416-02) / 1 KIT in 1 BLISTER PACKMarketed from Feb 18, 2015 | |
| 16714-416-03 | 1671404160316714041603 | 3 BLISTER PACK in 1 CARTON (16714-416-03) / 1 KIT in 1 BLISTER PACKMarketed from Feb 18, 2015 | |
| 16714-416-04 | 1671404160416714041604 | 6 BLISTER PACK in 1 CARTON (16714-416-04) / 1 KIT in 1 BLISTER PACKMarketed from Feb 18, 2015 |
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 24 Fe
- Generic name (nonproprietary)
- norethindrone acetate/ethinyl estradiol and ferrous fumarate
- Dosage form
- Kit
- Labeler
- Northstar Rx LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202994
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-416_6a455ad1-b63e-4f0b-b729-c10444ba9c18SPL ID 6a455ad1-b63e-4f0b-b729-c10444ba9c18SPL set ID ea35800c-9a31-42b0-bb32-3404dce9e0e5RxCUI 259176, 1358762, 1359117, 1605091
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
N416714041601followed by a unit qualifier and the quantityPackage 16714-0416-01. 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)
LARIN 24 Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by women to prevent pregnancy. (1) The efficacy of LARIN 24 Fe in women with a body mass index (BMI) of >35 kg/m 2 has not been evaluated. ( 1 , 8.8 ) Larin 24 Fe is indicated for use by women to prevent pregnancy [see Clinical Studies (14) ] . The efficacy of LARIN 24 Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated.
Excerpt only. Read the full label for complete information.
About NDC 16714-416
- What is NDC 16714-416?
- 16714-416 is the product NDC for Larin 24 Fe 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 24 Fe (Norethindrone acetate/Ethinyl Estradiol and Ferrous Fumarate).
- 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 24 Fe?
- 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 202994
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 24 Fenorethindrone acetate/ethinyl estradiol and ferrous fumarate | — | Kit | Mayne Pharma Inc. | 51862-648 |