Prescription drug · ANDA
Juleber (Desogestrel and ethinyl estradiol) NDC 16714-464
Kit · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-464-01 | 1671404640116714046401 | 1 BLISTER PACK in 1 PACKET (16714-464-01) / 1 KIT in 1 BLISTER PACKMarketed from Jul 12, 2013 | |
| 16714-464-02 | 1671404640216714046402 | 1 BLISTER PACK in 1 CARTON (16714-464-02) / 1 KIT in 1 BLISTER PACKMarketed from Jul 12, 2013 | |
| 16714-464-03 | 1671404640316714046403 | 3 BLISTER PACK in 1 CARTON (16714-464-03) / 1 KIT in 1 BLISTER PACKMarketed from Jul 12, 2013 | |
| 16714-464-04 | 1671404640416714046404 | 6 BLISTER PACK in 1 CARTON (16714-464-04) / 1 KIT in 1 BLISTER PACKMarketed from Jul 12, 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)
- Juleber
- Generic name (nonproprietary)
- desogestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Northstar Rx LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091234
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-464_4feaf19e-05de-4481-8e00-668b6f1f3870SPL ID 4feaf19e-05de-4481-8e00-668b6f1f3870SPL set ID de9a2d1b-15f6-453f-b36b-1c2a43c4918dRxCUI 240707, 748797, 749848, 1605086
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
N416714046401followed by a unit qualifier and the quantityPackage 16714-0464-01. 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 JULEBER™ 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 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 these methods can result in lower failure rates. In a clinical trial with desogestrel and ethinyl estradiol tablets 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were …
Excerpt only. Read the full label for complete information.
About NDC 16714-464
- What is NDC 16714-464?
- 16714-464 is the product NDC for Juleber 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?
- Juleber (Desogestrel 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 Juleber?
- 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 091234
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 |
|---|---|---|---|---|
| Desogestrel and Ethinyl Estradiol | — | Kit | Mayne Pharma Inc. | 51862-514 |