NDC codes

FDA NDC Directory
Product NDC (as listed)68071-3796Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-3796Add 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 NDC11-digit (billing)PackageCopy
68071-3796-4680713796041 TUBE in 1 CARTON (68071-3796-4) / 42.5 g in 1 TUBEMarketed from Feb 17, 2025

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 Vaginal
Generic name (nonproprietary)
estradiol
Active ingredients
Estradiol — .1 mg/g
Dosage form
Cream
Route
Vaginal
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210194
Marketing start
Listing expires
Other FDA classes
Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers
Product ID 68071-3796_2e5a4d85-1780-b878-e063-6394a90a4caaSPL ID 2e5a4d85-1780-b878-e063-6394a90a4caaSPL set ID 2e5a4d78-6683-4fb8-e063-6294a90a49e7RxCUI 310169UNII 4TI98Z838EUPC 0368071379648
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

N468071379604 followed by a unit qualifier and the quantity

Package 68071-3796-04. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 210194

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

FDA NDC Directory listings under ANDA 210194
ProductStrengthForm · routeLabelerProduct NDC
Estradiol VaginalestradiolEstradiol .1 mg/gCreamVaginalBryant Ranch Prepack71335-2831
Estradiol VaginalestradiolEstradiol .1 mg/gCreamVaginalBryant Ranch Prepack72162-1389
Estradiol VaginalestradiolEstradiol .1 mg/gCreamVaginalAvKARE42291-426
Estradiol VaginalestradiolEstradiol .1 mg/gCreamVaginalPadagis Israel Pharmaceuticals Ltd45802-097
Estradiol VaginalestradiolEstradiol .1 mg/gCreamVaginalBryant Ranch Prepack63629-8654
Estradiol VaginalestradiolEstradiol .1 mg/gCreamVaginalRedpharm Drug67296-2258
Estradiol VaginalestradiolEstradiol .1 mg/gCreamVaginalA-S Medication Solutions50090-7266

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