Prescription drug · ANDA
Larin Fe 1.5/30 NDC 16714-405
norethindrone acetate/ethinyl estradiol and ferrous fumarate · Kit · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-405-01 | 16714040501 | 1 BLISTER PACK in 1 PACKET (16714-405-01) / 1 KIT in 1 BLISTER PACKMarketed from Aug 23, 2013 | |
| 16714-405-02 | 16714040502 | 1 BLISTER PACK in 1 CARTON (16714-405-02) / 1 KIT in 1 BLISTER PACKMarketed from Aug 23, 2013 | |
| 16714-405-03 | 16714040503 | 3 BLISTER PACK in 1 CARTON (16714-405-03) / 1 KIT in 1 BLISTER PACKMarketed from Aug 23, 2013 | |
| 16714-405-04 | 16714040504 | 6 BLISTER PACK in 1 CARTON (16714-405-04) / 1 KIT in 1 BLISTER PACKMarketed from Aug 23, 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 1.5/30
- Generic name (nonproprietary)
- norethindrone acetate/ethinyl estradiol and ferrous fumarate
- Dosage form
- Kit
- Labeler
- Northstar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091453
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-405_9f9a5641-b363-47b9-849a-6f6095b7015bSPL ID 9f9a5641-b363-47b9-849a-6f6095b7015bSPL set ID ee79a7fa-1c64-4b7b-822c-e0ddefc8ef86RxCUI 259176, 1359022, 1359023, 1440937
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
N416714040501followed by a unit qualifier and the quantityPackage 16714-0405-01. 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 TM Fe 1.5/30 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: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD % of Women Experiencing an Unintended Pregnancy in the First Yea…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091453
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 1.5/30norethindrone acetate/ethinyl estradiol and ferrous fumarate | — | Kit | Proficient Rx LP | 82804-096 |
| Microgestin Fe 1.5/30norethindrone acetate/ethinyl estradiol and ferrous fumarate | — | Kit | Dr. Reddys Laboratories Inc | 75907-081 |
| Microgestin Fe 1.5/30norethindrone acetate/ethinyl estradiol and ferrous fumarate | — | Kit | Mayne Pharma Inc. | 51862-870 |