NDC codes

FDA NDC Directory
Product NDC (as listed)0093-3122Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-3122Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0093-3122-4200093312242000933122425 BLISTER PACK in 1 CARTON (0093-3122-42) / 28 TABLET in 1 BLISTER PACK (0093-3122-28)Marketed from Feb 17, 2011
0093-3122-98000933122980009331229890 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

N400093312242 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in