What is NDC 54348-701?

54348-701 is the product NDC for Estradiol, Estradiol 1 mg/1 tablet, listed with the FDA by PharmPak, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

PharmPak, Inc., NDC labeler code 54348. 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 54348-701 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)54348-701Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54348-0701Add 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
54348-701-30	5434807013054348070130	1 BOTTLE in 1 BOX (54348-701-30) / 30 TABLET in 1 BOTTLEMarketed from Jul 9, 2019

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 — 1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: PharmPak, Inc.NDC labeler code 54348
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040197
Marketing start: Jul 9, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers: Product ID 54348-701_2bd95a2b-6eee-e171-e063-6394a90a4e4aSPL ID 2bd95a2b-6eee-e171-e063-6394a90a4e4aSPL set ID 20b50139-4e13-4f0c-aaf5-ecb83911d9e6RxCUI 197658UNII 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

N454348070130 followed by a unit qualifier and the quantity

Package 54348-0701-30. 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 Jan 16, 2025. 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 54348-701

What is NDC 54348-701?: 54348-701 is the product NDC for Estradiol, Estradiol 1 mg/1 tablet, listed with the FDA by PharmPak, 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?: PharmPak, Inc., NDC labeler code 54348. 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 040197

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

FDA NDC Directory listings under ANDA 040197
Product	Strength	Form · route	Labeler	Product NDC
Estradiol	Estradiol 1 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0555-0886
Estradiol	Estradiol 2 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0555-0887
Estradiol	Estradiol .5 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0555-0899
Estradiol	Estradiol 1 mg/1	TabletOral	A-S Medication Solutions	50090-1704
Estradiol	Estradiol .5 mg/1	TabletOral	A-S Medication Solutions	50090-1882
Estradiol	Estradiol 1 mg/1	TabletOral	A-S Medication Solutions	50090-6847
Estradiol	Estradiol 2 mg/1	TabletOral	Northwind Health Company, LLC	51655-227
Estradiol	Estradiol 1 mg/1	TabletOral	Northwind Health Company, LLC	51655-229
Estradiol	Estradiol 2 mg/1	TabletOral	PharmPak, Inc.	54348-702
Estradiol	Estradiol 1 mg/1	TabletOral	American Health Packaging	60687-876
Estradiol	Estradiol 1 mg/1	TabletOral	Proficient Rx LP	63187-741
Estradiol	Estradiol .5 mg/1	TabletOral	Bryant Ranch Prepack	63629-8802
Estradiol	Estradiol 1 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2487
Estradiol	Estradiol 2 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2675
Estradiol	Estradiol 2 mg/1	TabletOral	REMEDYREPACK INC.	70518-2369
Estradiol	Estradiol 2 mg/1	TabletOral	Bryant Ranch Prepack	71335-0201
Estradiol	Estradiol .5 mg/1	TabletOral	Bryant Ranch Prepack	71335-0430
Estradiol	Estradiol 1 mg/1	TabletOral	Bryant Ranch Prepack	71335-0445
Estradiol	Estradiol 1 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-299
Estradiol	Estradiol 2 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-360