Prescription drug · ANDA
Sharobel (Norethindrone) NDC 16714-441
Kit · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-441-01 | 16714044101 | 1 BLISTER PACK in 1 PACKET (16714-441-01) / 1 KIT in 1 BLISTER PACKMarketed from Sep 13, 2013 | |
| 16714-441-02 | 16714044102 | 1 BLISTER PACK in 1 CARTON (16714-441-02) / 1 KIT in 1 BLISTER PACKMarketed from Jan 1, 2020 | |
| 16714-441-03 | 16714044103 | 3 BLISTER PACK in 1 CARTON (16714-441-03) / 1 KIT in 1 BLISTER PACKMarketed from Jan 1, 2020 | |
| 16714-441-04 | 16714044104 | 6 BLISTER PACK in 1 CARTON (16714-441-04) / 1 KIT in 1 BLISTER PACKMarketed from Sep 13, 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)
- Sharobel
- Generic name (nonproprietary)
- norethindrone
- Dosage form
- Kit
- Labeler
- Northstar Rx LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200961
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-441_bc5880ea-5359-4f40-a2e5-7af0b1131a9cSPL ID bc5880ea-5359-4f40-a2e5-7af0b1131a9cSPL set ID a96f5194-ad2a-4783-a9a9-22a288caff25RxCUI 198042, 748961, 1539955
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
N416714044101followed by a unit qualifier and the quantityPackage 16714-0441-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE 1. Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception. Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an Unintended Pregnancy within the Fi…
Excerpt only. Read the full label for complete information.
About NDC 16714-441
- What is NDC 16714-441?
- 16714-441 is the product NDC for Sharobel (norethindrone) 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?
- Sharobel (Norethindrone).
- 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 Sharobel?
- 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.