What is NDC 76420-021?

76420-021 is the product NDC for Estradiol, Estradiol .5 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Asclemed USA, Inc., NDC labeler code 76420. 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?

182 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 76420-021 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-021Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0021Add 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
76420-021-10	7642000211076420002110	100 TABLET in 1 BOTTLE (76420-021-10)Marketed from Sep 29, 2020

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 — .5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040275
Marketing start: Apr 10, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers: Product ID 76420-021_ead12b79-385c-4dee-e053-2a95a90ac9daSPL ID ead12b79-385c-4dee-e053-2a95a90ac9daSPL set ID 229b4ec5-d3c8-4406-9fc5-8f633c6447b8RxCUI 197657, 197658, 197659UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N476420002110 followed by a unit qualifier and the quantity

Package 76420-0021-10. 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 12, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Estradiol tablets are indicated in the: Treatment of moderate to severe vasomotor symptoms associated with the menopause. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). Prevention of osteoporosis. W…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-021

What is NDC 76420-021?: 76420-021 is the product NDC for Estradiol, Estradiol .5 mg/1 tablet, listed with the FDA by Asclemed USA, 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?: Asclemed USA, Inc., NDC labeler code 76420. 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?: 182 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 183 Estradiol NDCs

Other NDCs under ANDA 040275

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

FDA NDC Directory listings under ANDA 040275
Product	Strength	Form · route	Labeler	Product NDC
Estradiol	Estradiol 2 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4485
Estradiol	Estradiol .5 mg/1	TabletOral	A-S Medication Solutions	50090-5494
Estradiol	Estradiol .5 mg/1	TabletOral	PURACAP LABORATORIES, LLC	24658-702
Estradiol	Estradiol 1 mg/1	TabletOral	PURACAP LABORATORIES, LLC	24658-703
Estradiol	Estradiol 2 mg/1	TabletOral	PURACAP LABORATORIES, LLC	24658-704
Estradiol	Estradiol 1 mg/1	TabletOral	Bryant Ranch Prepack	71335-0797
Estradiol	Estradiol .5 mg/1	TabletOral	Bryant Ranch Prepack	71335-0226
Estradiol	Estradiol 1 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7102
Estradiol	Estradiol 1 mg/1	TabletOral	A-S Medication Solutions	50090-7452
Estradiol	Estradiol 1 mg/1	TabletOral	REMEDYREPACK INC.	70518-3818
Estradiol	Estradiol 1 mg/1	TabletOral	EPIC PHARMA, LLC	42806-088
Estradiol	Estradiol 2 mg/1	TabletOral	Bryant Ranch Prepack	63629-4788
Estradiol	Estradiol .5 mg/1	TabletOral	EPIC PHARMA, LLC	42806-087
Estradiol	Estradiol 2 mg/1	TabletOral	EPIC PHARMA, LLC	42806-089
Estradiol	Estradiol 1 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3394
Estradiol	Estradiol 1 mg/1	TabletOral	Asclemed USA, Inc.	76420-022
Estradiol	Estradiol 1 mg/1	TabletOral	Asclemed USA, Inc.	76420-022
Estradiol	Estradiol 2 mg/1	TabletOral	Asclemed USA, Inc.	76420-023
Estradiol	Estradiol 2 mg/1	TabletOral	Asclemed USA, Inc.	76420-023
Estradiol	Estradiol 1 mg/1	TabletOral	Direct_Rx	72189-502

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