Prescription drug · ANDA
Larin Fe 1/20 NDC 16714-406
norethindrone acetate/ethinyl estradiol and ferrous fumarate · Kit · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-406-01 | 1671404060116714040601 | 1 BLISTER PACK in 1 PACKET (16714-406-01) / 1 KIT in 1 BLISTER PACKMarketed from Aug 26, 2013 | |
| 16714-406-02 | 1671404060216714040602 | 1 BLISTER PACK in 1 CARTON (16714-406-02) / 1 KIT in 1 BLISTER PACKMarketed from Aug 26, 2013 | |
| 16714-406-03 | 1671404060316714040603 | 3 BLISTER PACK in 1 CARTON (16714-406-03) / 1 KIT in 1 BLISTER PACKMarketed from Aug 26, 2013 | |
| 16714-406-04 | 1671404060416714040604 | 6 BLISTER PACK in 1 CARTON (16714-406-04) / 1 KIT in 1 BLISTER PACKMarketed from Aug 26, 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 Fe 1/20
- 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 091454
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-406_09cca9eb-091f-4261-8493-a6d70af1d03aSPL ID 09cca9eb-091f-4261-8493-a6d70af1d03aSPL set ID e71741c8-10fa-4eee-b0da-e42af451222cRxCUI 259176, 1358762, 1358763, 1440183
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
N416714040601followed by a unit qualifier and the quantityPackage 16714-0406-01. 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™ Fe 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. Adapted from RA Hatcher et al, Reference 7. TABLE I LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD % of Women Experiencing a…
Excerpt only. Read the full label for complete information.
About NDC 16714-406
- What is NDC 16714-406?
- 16714-406 is the product NDC for Larin Fe 1/20 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 Fe 1/20 (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 Fe 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 091454
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 Fe 1/20norethindrone acetate/ethinyl estradiol and ferrous fumarate | — | Kit | Mayne Pharma Inc. | 51862-866 |
| Microgestin Fe 1/20norethindrone acetate/ethinyl estradiol and ferrous fumarate | — | Kit | Dr. Reddy's Laboratories Inc. | 75907-082 |