NDC codes

FDA NDC Directory
Product NDC (as listed)68025-066Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68025-0066Add 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
68025-066-07680250066077 PACKET in 1 CARTON (68025-066-07) / .5 g in 1 PACKETMarketed from Oct 27, 2014
68025-066-306802500663030 PACKET in 1 CARTON (68025-066-30) / .5 g in 1 PACKETMarketed from Oct 27, 2014

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)
Divigel
Generic name (nonproprietary)
estradiol
Active ingredients
Estradiol — .5 mg/.5g
Dosage form
Gel
Route
Topical
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022038
Marketing start
Listing expires
Other FDA classes
Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers
Product ID 68025-066_077120b4-1172-49bc-b197-363f410589abSPL ID 077120b4-1172-49bc-b197-363f410589abSPL set ID 59e610dc-883e-4f07-9ec6-a5841b0bf9fbRxCUI 2619677, 2619678, 2619679, 2619680, 2619681, 2619682, 2619683, 2619684, 2619685, 2619686UNII 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

N468025006607 followed by a unit qualifier and the quantity

Package 68025-0066-07. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Divigel 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)

Other NDCs under NDA 022038

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

FDA NDC Directory listings under NDA 022038
ProductStrengthForm · routeLabelerProduct NDC
EstradiolEstradiol .25 mg/.25gGelTopicalTrigen Laboratories, LLC13811-090
EstradiolEstradiol 1 mg/gGelTopicalTrigen Laboratories, LLC13811-093
EstradiolEstradiol .5 mg/.5gGelTopicalTrigen Laboratories, LLC13811-091
EstradiolEstradiol .75 mg/.75gGelTopicalTrigen Laboratories, LLC13811-092
EstradiolEstradiol 1.25 mg/1.25gGelTopicalTrigen Laboratories, LLC13811-094
DivigelestradiolEstradiol .25 mg/.25gGelTopicalVertical Pharmaceuticals, LLC68025-065
DivigelestradiolEstradiol 1 mg/gGelTopicalVertical Pharmaceuticals, LLC68025-067
DivigelestradiolEstradiol 1.25 mg/1.25gGelTopicalVertical Pharmaceuticals, LLC68025-086
DivigelestradiolEstradiol .75 mg/.75gGelTopicalVertical Pharmaceuticals, LLC68025-083

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