What is NDC 69238-1521?

69238-1521 is the product NDC for Norelgestromin and Ethinly Estradiol, Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d patch, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Norelgestromin, Ethinyl estradiol.

Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Norelgestromin and Ethinly Estradiol?

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.

Norelgestromin and Ethinly Estradiol NDC 69238-1521

NDC codes

FDA NDC Directory

Product NDC (as listed)69238-1521Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69238-1521Add 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
69238-1521-3	6923815210369238152103	3 POUCH in 1 CARTON (69238-1521-3) / 1 PATCH in 1 POUCH (69238-1521-1) / 7 d in 1 PATCHMarketed from Feb 26, 2021

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 Ethinly Estradiol
Generic name (nonproprietary): norelgestromin and ethinly estradiol
Active ingredients: Norelgestromin — 150 ug/dEthinyl estradiol — 35 ug/d
Dosage form: Patch
Route: Transdermal
Labeler: Amneal Pharmaceuticals NY LLCNDC labeler code 69238
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213950
Marketing start: Feb 26, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 69238-1521_0a63a330-c4d1-4fb0-8e11-10b2971f1a57SPL ID 0a63a330-c4d1-4fb0-8e11-10b2971f1a57SPL set ID 36445b6a-e0f2-42f7-a8f3-5b80c90b87ddRxCUI 1534809UNII 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

N469238152103 followed by a unit qualifier and the quantity

Package 69238-1521-03. 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 Mar 30, 2022. 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/m 2 [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 (CHC…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69238-1521

What is NDC 69238-1521?: 69238-1521 is the product NDC for Norelgestromin and Ethinly Estradiol, Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d patch, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Norelgestromin and Ethinly Estradiol.
What is the active ingredient?: Norelgestromin, Ethinyl estradiol.
Who is the labeler?: Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Norelgestromin and Ethinly Estradiol?: 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 213950

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

FDA NDC Directory listings under ANDA 213950
Product	Strength	Form · route	Labeler	Product NDC
Zafemynorelgestromin and ethinyl estradiol	Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d	PatchTransdermal	AvKARE	42291-930
Zafemynorelgestromin and ethinyl estradiol	Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d	PatchTransdermal	Amneal Pharmaceuticals LLC	65162-358
Zafemynorelgestromin and ethinyl estradiol	Norelgestromin 150 ug/d; Ethinyl estradiol 35 ug/d	PatchTransdermal	Bryant Ranch Prepack	72162-2220