Xulane NDC 0378-3340

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-3340Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-3340Add 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 NDC	11-digit (billing)	Package	Copy
0378-3340-53	00378334053	3 POUCH in 1 CARTON (0378-3340-53) / 1 PATCH in 1 POUCH (0378-3340-16) / 7 d in 1 PATCHMarketed from Apr 16, 2014

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): Xulane
Generic name (nonproprietary): norelgestromin and ethinyl estradiol
Active ingredients: Norelgestromin — 150 ug/dEthinyl estradiol — 35 ug/d
Dosage form: Patch
Route: Transdermal
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200910
Marketing start: Apr 16, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 0378-3340_fb5b221c-cac1-4530-9c98-d485754a8266SPL ID fb5b221c-cac1-4530-9c98-d485754a8266SPL set ID f7848550-086a-43d8-8ae5-047f4b9e4382RxCUI 1534809, 1536586UNII R0TAY3X631, 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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400378334053 followed by a unit qualifier and the quantity

Package 00378-3340-53. 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 Mar 4, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Xulane 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: Xulane may be less effective in preventing pregnancy in women who weigh 198 lbs. (90 kg) or more. Xulane is contraindicated for use in women with BMI ≥ 30 kg/m 2 [see Contraindications (4) , Warnings and Precautions (5.1) and Clinical Studies (14) ] . Xulane is an estrogen/progestin combination hormonal contraceptive (CHC), indicated for the prevention of pregnancy in women with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. ( 1 ) Limitations of Use: Xulane may be less effective in pr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200910

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

FDA NDC Directory listings under ANDA 200910
Product	Strength	Form · route	Labeler	Product NDC
Xulanenorelgestromin and ethinyl estradiol	Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d	PatchTransdermal	A-S Medication Solutions	50090-1683