Prescription drug · ANDA
Jinteli NDC 0093-3122
norethindrone acetate and ethinyl estradiol · Norethindrone acetate 1 mg/1; Ethinyl estradiol 5 ug/1 · Tablet · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-3122-42 | 0009331224200093312242 | 5 BLISTER PACK in 1 CARTON (0093-3122-42) / 28 TABLET in 1 BLISTER PACK (0093-3122-28)Marketed from Feb 17, 2011 | |
| 0093-3122-98 | 0009331229800093312298 | 90 TABLET in 1 BOTTLE (0093-3122-98)Marketed from Feb 17, 2011 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Jinteli
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol
- Active ingredients
- Norethindrone acetate — 1 mg/1Ethinyl estradiol — 5 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076221
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 0093-3122_ae9e248a-d907-4316-b96f-485d4769fa5cSPL ID ae9e248a-d907-4316-b96f-485d4769fa5cSPL set ID d667ca75-1a17-43fc-9077-f25ce0908f8dRxCUI 1090992, 1090996UNII 9S44LIC7OJ, 423D2T571U
- Pharmacologic class
- Estrogen; Progestin
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
N400093312242followed by a unit qualifier and the quantityPackage 00093-3122-42. 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)
Jinteli is a combination of an estrogen and progestin indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) Prevention of Postmenopausal Osteoporosis ( 1.2 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
Excerpt only. Read the full label for complete information.
About NDC 0093-3122
- What is NDC 0093-3122?
- 0093-3122 is the product NDC for Jinteli, Norethindrone acetate 1 mg/1; Ethinyl estradiol 5 ug/1 tablet, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Jinteli (Norethindrone acetate and ethinyl estradiol).
- What is the active ingredient?
- Norethindrone acetate, Ethinyl estradiol.
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Jinteli?
- 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.