Estradiol NDC 0378-4621

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-4621Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-4621Add 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
0378-4621-26	00378462126	8 POUCH in 1 CARTON (0378-4621-26) / 1 PATCH in 1 POUCH (0378-4621-16) / 3.5 d in 1 PATCHMarketed from Nov 1, 2018

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): Estradiol
Generic name (nonproprietary): estradiol
Active ingredients: Estradiol — .05 mg/d
Dosage form: Patch
Route: Transdermal
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206685
Marketing start: Nov 1, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers: Product ID 0378-4621_e3b94477-b715-40f6-bbbb-fe52a87148ddSPL ID e3b94477-b715-40f6-bbbb-fe52a87148ddSPL set ID f4efb0bf-b96f-4e20-a0f2-0806ab92b2d4RxCUI 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

N400378462126 followed by a unit qualifier and the quantity

Package 00378-4621-26. 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 Jun 23, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Estradiol transdermal system (twice-weekly) is indicated for: Estradiol transdermal system (twice-weekly) 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, …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206685

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

FDA NDC Directory listings under ANDA 206685
Product	Strength	Form · route	Labeler	Product NDC
Estradiol	Estradiol .025 mg/d	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-4619
Estradiol	Estradiol .0375 mg/d	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-4620
Estradiol	Estradiol .075 mg/d	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-4622
Estradiol	Estradiol .1 mg/d	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-4623