Prescription drug · ANDA
Wera (Norethindrone and ethinyl estradiol) NDC 16714-370
Kit · Oral · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-370-01 | 1671403700116714037001 | 1 BLISTER PACK in 1 PACKET (16714-370-01) / 1 KIT in 1 BLISTER PACKMarketed from Mar 27, 2012 | |
| 16714-370-02 | 1671403700216714037002 | 1 BLISTER PACK in 1 CARTON (16714-370-02) / 1 KIT in 1 BLISTER PACKMarketed from Mar 27, 2012 | |
| 16714-370-03 | 1671403700316714037003 | 3 BLISTER PACK in 1 CARTON (16714-370-03) / 1 KIT in 1 BLISTER PACKMarketed from Mar 27, 2012 | |
| 16714-370-04 | 1671403700416714037004 | 6 BLISTER PACK in 1 CARTON (16714-370-04) / 1 KIT in 1 BLISTER PACKMarketed from Mar 27, 2012 |
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)
- Wera
- Generic name (nonproprietary)
- norethindrone and ethinyl estradiol
- Dosage form
- Kit
- Route
- Oral
- Labeler
- Northstar Rx LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091204
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-370_1f26d981-43da-4b0e-bee1-7d195254fb77SPL ID 1f26d981-43da-4b0e-bee1-7d195254fb77SPL set ID 638e4f36-1a27-4220-8ec9-3fa9d9b36c11RxCUI 310463, 748797, 749879, 1300911
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N416714037001followed by a unit qualifier and the quantityPackage 16714-0370-01. 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 WERA™ Tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the NORPLANT ® System depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. 9 …
Excerpt only. Read the full label for complete information.
About NDC 16714-370
- What is NDC 16714-370?
- 16714-370 is the product NDC for Wera 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?
- Wera (Norethindrone and ethinyl estradiol).
- 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 Wera?
- 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 091204
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 |
|---|---|---|---|---|
| Neconnorethindrone and ethinyl estradiol | — | KitOral | Mayne Pharma Inc. | 51862-892 |
| Neconnorethindrone and ethinyl estradiol | — | KitOral | Dr. Reddy's Laboratories Inc. | 75907-085 |