Prescription drug · ANDA
Larin 1.5/30 (norethindrone acetate/ethinyl estradiol) NDC 16714-407
Kit · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-407-01 | 16714040701 | 1 BLISTER PACK in 1 PACKET (16714-407-01) / 1 KIT in 1 BLISTER PACKMarketed from Mar 20, 2014 | |
| 16714-407-02 | 16714040702 | 1 BLISTER PACK in 1 CARTON (16714-407-02) / 1 KIT in 1 BLISTER PACKMarketed from Mar 20, 2014 | |
| 16714-407-03 | 16714040703 | 3 BLISTER PACK in 1 CARTON (16714-407-03) / 1 KIT in 1 BLISTER PACKMarketed from Mar 20, 2014 | |
| 16714-407-04 | 16714040704 | 6 BLISTER PACK in 1 CARTON (16714-407-04) / 1 KIT in 1 BLISTER PACKMarketed from Mar 20, 2014 |
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 1.5/30
- Generic name (nonproprietary)
- norethindrone acetate/ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Northstar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202996
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-407_3136be5c-9efe-44d1-9e31-6f4ab797bfe4SPL ID 3136be5c-9efe-44d1-9e31-6f4ab797bfe4SPL set ID e232ed29-e6f5-4591-8d61-68eb8b1596f0RxCUI 1359022, 1359028, 1537209
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
N416714040701followed by a unit qualifier and the quantityPackage 16714-0407-01. 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™ 1.5/30 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. table1
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202996
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 1.5/30norethindrone acetate/ethinyl estradiol | — | Kit | Dr. Reddys Laboratories Inc. | 75907-083 |
| Microgestin 1.5/30norethindrone acetate/ethinyl estradiol | — | Kit | Mayne Pharma Inc. | 51862-872 |