What is NDC 0378-4644?

0378-4644 is the product NDC for Estradiol, Estradiol .025 mg/d patch, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 0378-4644 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-4644Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-4644Add 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
0378-4644-26	00378464426	8 POUCH in 1 CARTON (0378-4644-26) / 1 PATCH in 1 POUCH (0378-4644-16) / 3.5 d in 1 PATCHMarketed from Dec 19, 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): Estradiol
Generic name (nonproprietary): estradiol
Active ingredients: Estradiol — .025 mg/d
Dosage form: Patch
Route: Transdermal
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201675
Marketing start: Dec 19, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers: Product ID 0378-4644_e1deb37a-8362-4275-a04c-7abcbb2e9f56SPL ID e1deb37a-8362-4275-a04c-7abcbb2e9f56SPL set ID d28bec8f-762e-4f05-a20d-96a42970d6a7RxCUI 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

N400378464426 followed by a unit qualifier and the quantity

Package 00378-4644-26. 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 17, 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 ) • Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause ( 1.2 ) Limitations of Use When prescribing solely for the treatment of moderate to severe vaginal atrophy, first consider the use of topical vaginal products. • Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure ( 1.3 ) • Prevention of postmenopausal osteoporosis ( 1.4 ) Limitations of Use When prescribing solely for the prevention of postmenopausal osteo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-4644

What is NDC 0378-4644?: 0378-4644 is the product NDC for Estradiol, Estradiol .025 mg/d patch, listed with the FDA by Mylan Pharmaceuticals Inc.. 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 201675

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

FDA NDC Directory listings under ANDA 201675
Product	Strength	Form · route	Labeler	Product NDC
Estradiol	Estradiol .1 mg/d	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-4640
Estradiol	Estradiol .075 mg/d	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-4641
Estradiol	Estradiol .05 mg/d	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-4642
Estradiol	Estradiol .0375 mg/d	PatchTransdermal	Mylan Pharmaceuticals Inc.	0378-4643