What is NDC 0037-4801?

0037-4801 is the product NDC for Elestrin (estradiol), Estradiol .52 mg/.87g gel, metered, listed with the FDA by Viatris Specialty LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Viatris Specialty LLC, NDC labeler code 0037. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Elestrin?

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.

Elestrin NDC 0037-4801 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0037-4801Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00037-4801Add 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
0037-4801-70	00037480170	2 BOTTLE, PUMP in 1 CARTON (0037-4801-70) / 35 g in 1 BOTTLE, PUMP (0037-4801-35)Marketed from Nov 5, 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): Elestrin
Generic name (nonproprietary): estradiol
Active ingredients: Estradiol — .52 mg/.87g
Dosage form: Gel, Metered
Route: Topical
Labeler: Viatris Specialty LLCNDC labeler code 0037
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021813
Marketing start: Jun 2, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers: Product ID 0037-4801_1246f55c-8c45-4fbd-af2c-91bb74e8310bSPL ID 1246f55c-8c45-4fbd-af2c-91bb74e8310bSPL set ID eff2dea1-f117-11e3-ac10-0800200c9a66RxCUI 226597, 706467UNII 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

N400037480170 followed by a unit qualifier and the quantity

Package 00037-4801-70. 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 Dec 15, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

ELESTRIN is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause ( 1.1 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0037-4801

What is NDC 0037-4801?: 0037-4801 is the product NDC for Elestrin (estradiol), Estradiol .52 mg/.87g gel, metered, listed with the FDA by Viatris Specialty LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Elestrin (Estradiol).
What is the active ingredient?: Estradiol.
Who is the labeler?: Viatris Specialty LLC, NDC labeler code 0037. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Elestrin?: 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.

Elestrin (Estradiol) NDC 0037-4801