What is NDC 70954-646?

70954-646 is the product NDC for Estradiol, Estradiol .75 mg/1.25g gel, metered, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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?

184 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 70954-646 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70954-646Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70954-0646Add 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
70954-646-10	70954064610	50 g in 1 BOTTLE, PUMP (70954-646-10)Marketed from Oct 23, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — .75 mg/1.25g
Dosage form: Gel, Metered
Route: Topical
Labeler: ANI Pharmaceuticals, Inc.NDC labeler code 70954
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217882
Marketing start: Oct 23, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers: Product ID 70954-646_3518120e-cc44-4d70-8a20-0ef2dce9a3c6SPL ID 3518120e-cc44-4d70-8a20-0ef2dce9a3c6SPL set ID 3518120e-cc44-4d70-8a20-0ef2dce9a3c6RxCUI 226597UNII 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N470954064610 followed by a unit qualifier and the quantity

Package 70954-0646-10. 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 Oct 28, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Estradiol gel 0.06% 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) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause . 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitation of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70954-646

What is NDC 70954-646?: 70954-646 is the product NDC for Estradiol, Estradiol .75 mg/1.25g gel, metered, listed with the FDA by ANI 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?: ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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?: 184 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
Estradiolestradiol transdermal	Estradiol 1 mg/g	GelTopical	Amneal Pharmaceuticals NY LLC	69238-2449	69238-2449-03
Estradiolestradiol transdermal	Estradiol 1.25 mg/1.25g	GelTopical	Amneal Pharmaceuticals NY LLC	69238-2448	69238-2448-03
Estradiolestradiol transdermal	Estradiol .75 mg/.75g	GelTopical	Amneal Pharmaceuticals NY LLC	69238-2450	69238-2450-03
Estradiolestradiol transdermal	Estradiol .5 mg/.5g	GelTopical	Amneal Pharmaceuticals NY LLC	69238-2451	69238-2451-03

All 185 Estradiol NDCs