What is NDC 63629-8713?

63629-8713 is the product NDC for Estradiol, Estradiol hemihydrate .1 mg/g cream, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 63629. 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 63629-8713 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8713Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8713Add 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
63629-8713-1	6362987130163629871301	1 TUBE, WITH APPLICATOR in 1 CARTON (63629-8713-1) / 42.5 g in 1 TUBE, WITH APPLICATORMarketed from Aug 19, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 hemihydrate — .1 mg/g
Dosage form: Cream
Route: Vaginal
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209767
Marketing start: Mar 5, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers: Product ID 63629-8713_06e2b88b-16e5-4926-bc67-7ca1c1f9156fSPL ID 06e2b88b-16e5-4926-bc67-7ca1c1f9156fSPL set ID 74baff07-15df-48a8-93b8-3a317f896a56RxCUI 310169UNII CXY7B3Q98Z
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N463629871301 followed by a unit qualifier and the quantity

Package 63629-8713-01. 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 Aug 30, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Estradiol Vaginal Cream 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-8713

What is NDC 63629-8713?: 63629-8713 is the product NDC for Estradiol, Estradiol hemihydrate .1 mg/g cream, listed with the FDA by Bryant Ranch Prepack. 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 hemihydrate.
Who is the labeler?: Bryant Ranch Prepack, NDC labeler code 63629. 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 209767

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

FDA NDC Directory listings under ANDA 209767
Product	Strength	Form · route	Labeler	Product NDC
Estradiol	Estradiol hemihydrate .1 mg/g	CreamVaginal	Alvogen Inc.	47781-104
Estradiol	Estradiol hemihydrate .1 mg/g	CreamVaginal	A-S Medication Solutions	50090-3645
Estradiol Vaginalestradiol	Estradiol hemihydrate .1 mg/g	CreamVaginal	Encube Ethicals, Inc.	21922-085
Estradiol Vaginalestradiol	Estradiol hemihydrate .1 mg/g	CreamVaginal	Redpharm Drug	67296-2303