What is NDC 69238-1295?

69238-1295 is the product NDC for Estradiol, Estradiol .05 mg/d patch, extended release, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

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 Estradiol?

181 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Estradiol NDC 69238-1295 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69238-1295Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69238-1295Add 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
69238-1295-7	69238129507	8 POUCH in 1 CARTON (69238-1295-7) / 1 d in 1 POUCH (69238-1295-1)Marketed from Sep 30, 2020

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): Estradiol
Generic name (nonproprietary): estradiol
Active ingredients: Estradiol — .05 mg/d
Dosage form: Patch, Extended release
Route: Transdermal
Labeler: Amneal Pharmaceuticals NY LLCNDC labeler code 69238
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211396
Marketing start: Sep 30, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers: Product ID 69238-1295_257bffaf-8bc9-4557-a1e3-bab40bee2fb7SPL ID 257bffaf-8bc9-4557-a1e3-bab40bee2fb7SPL set ID d4259bb8-91f8-4587-8ceb-35d44145aec0RxCUI 241946, 242891, 242892, 248478, 1149632UNII 4TI98Z838E
Pharmacologic class: Estrogen

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

N469238129507 followed by a unit qualifier and the quantity

Package 69238-1295-07. 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 May 15, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Estradiol transdermal system is indicated for: Estradiol transdermal system is an estrogen indicated for: Treatment of moderate to severe vasomotor symptoms due to menopause ( 1.1 ) Prevention of postmenopausal osteoporosis ( 1.2 ) Limitations of Use When prescribing solely for the treatment of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. 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-estr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69238-1295

What is NDC 69238-1295?: 69238-1295 is the product NDC for Estradiol, Estradiol .05 mg/d patch, extended release, 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?: Estradiol.
What is the active ingredient?: 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 Estradiol?: 181 other product NDCs are listed under this name. See all Estradiol NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Estradiol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Estradiol	Estradiol .75 mg/1.25g	GelTransdermal	Encube Ethicals, Inc.	21922-015	21922-0015-40
Estradiol	Estradiol .75 mg/1.25g	GelTopical	Solaris Pharma Corporation	73473-308	73473-0308-50
Estradiol	Estradiol .5 mg/1	TabletOral	Direct_Rx	72189-655	72189-0655-60
Estradiol	Estradiol .5 mg/1	TabletOral	Coupler LLC	67046-1568	67046-1568-03
Estradiol	Estradiol 1 mg/1	TabletOral	American Health Packaging	60687-876	60687-0876-65
Estradiol	Estradiol 1 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8860	68788-8860-0168788-8860-0368788-8860-06+1 more
Estradiol	Estradiol .75 mg/1.25g	Gel, MeteredTopical	ANI Pharmaceuticals, Inc.	70954-646	70954-0646-10
Estradiolestradiol transdermal	Estradiol 1.25 mg/1.25g	GelTopical	Amneal Pharmaceuticals NY LLC	69238-2448	69238-2448-03
Estradiolestradiol transdermal	Estradiol 1 mg/g	GelTopical	Amneal Pharmaceuticals NY LLC	69238-2449	69238-2449-03
Estradiolestradiol transdermal	Estradiol .75 mg/.75g	GelTopical	Amneal Pharmaceuticals NY LLC	69238-2450	69238-2450-03

All 182 Estradiol NDCs

Other NDCs under ANDA 211396

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

FDA NDC Directory listings under ANDA 211396
Product	Strength	Form · route	Labeler	Product NDC
Estradiol	Estradiol .0375 mg/d	Patch, Extended releaseTransdermal	Amneal Pharmaceuticals NY LLC	69238-1293
Estradiol	Estradiol .075 mg/d	Patch, Extended releaseTransdermal	Amneal Pharmaceuticals NY LLC	69238-1294
Estradiol	Estradiol .1 mg/d	Patch, Extended releaseTransdermal	Amneal Pharmaceuticals NY LLC	69238-1296
Estradiol	Estradiol .025 mg/d	Patch, Extended releaseTransdermal	Amneal Pharmaceuticals NY LLC	69238-1447
Lyllanaestradiol	Estradiol .025 mg/d	Patch, Extended releaseTransdermal	Amneal Pharmaceuticals LLC	65162-126
Lyllanaestradiol	Estradiol .0375 mg/d	Patch, Extended releaseTransdermal	Amneal Pharmaceuticals LLC	65162-148
Lyllanaestradiol	Estradiol .05 mg/d	Patch, Extended releaseTransdermal	Amneal Pharmaceuticals LLC	65162-149
Lyllanaestradiol	Estradiol .075 mg/d	Patch, Extended releaseTransdermal	Amneal Pharmaceuticals LLC	65162-150
Lyllanaestradiol	Estradiol .1 mg/d	Patch, Extended releaseTransdermal	Amneal Pharmaceuticals LLC	65162-228