NDC codes

FDA NDC Directory
Product NDC (as listed)70710-1190Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70710-1190Add 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
70710-1190-3707101190033 POUCH in 1 CARTON (70710-1190-3) / 1 POUCH in 1 POUCH (70710-1190-1) / 7 mg in 1 POUCHMarketed from Nov 21, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
norelgestromin and ethinyl estradiol
Generic name (nonproprietary)
norelgestromin and ethinyl estradiol
Active ingredients
Norelgestromin — 150 ug/mgEthinyl estradiol — 35 ug/mg
Dosage form
Patch
Route
Transdermal
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214594
Marketing start
Listing expires
Other FDA classes
Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers
Product ID 70710-1190_404277f1-4343-462c-b508-10c22dc7bc2cSPL ID 404277f1-4343-462c-b508-10c22dc7bc2cSPL set ID 10fa1458-c8ed-4197-922a-1ba7271d2b02RxCUI 1534809UNII R0TAY3X631, 423D2T571UUPC 0370710119034
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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N470710119003 followed by a unit qualifier and the quantity

Package 70710-1190-03. 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)

Norelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use: Norelgestromin and ethinyl estradiol transdermal system may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. Norelgestromin and ethinyl estradiol transdermal system is contraindicated for use in women with BMI ≥ 30 kg/m2 [ see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ) and Clinical Studies ( 14 ) ]. Norelgestromin and ethinyl estradiol transdermal system is an estrogen/progestin combination hormonal contraceptive (…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214594

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 214594
ProductStrengthForm · routeLabelerProduct NDC
norelgestromin and ethinyl estradiolNorelgestromin 150 ug/mg; Ethinyl estradiol 35 ug/mgPatchTransdermalZydus Lifesciences Limited70771-1777

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