Prescription drug · NDA
Divigel (Estradiol) NDC 68025-067
Estradiol 1 mg/g · Gel · Topical · Vertical Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68025-067-07 | 6802500670768025006707 | 7 PACKET in 1 CARTON (68025-067-07) / 1 g in 1 PACKETMarketed from Oct 27, 2014 | |
| 68025-067-30 | 6802500673068025006730 | 30 PACKET in 1 CARTON (68025-067-30) / 1 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 — 1 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Vertical Pharmaceuticals, LLCNDC labeler code 68025
- 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 68025-067_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
N468025006707followed by a unit qualifier and the quantityPackage 68025-0067-07. 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.
About NDC 68025-067
- What is NDC 68025-067?
- 68025-067 is the product NDC for Divigel (estradiol), Estradiol 1 mg/g gel, listed with the FDA by Vertical Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Divigel (Estradiol).
- What is the active ingredient?
- Estradiol.
- Who is the labeler?
- Vertical Pharmaceuticals, LLC, NDC labeler code 68025. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Divigel?
- 4 other product NDCs are listed under this name. See all Divigel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Divigel products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Divigelestradiol | Estradiol 1.25 mg/1.25g | GelTopical | Vertical Pharmaceuticals, LLC | 68025-086 | 68025-0086-0768025-0086-30 |
| Divigelestradiol | Estradiol .75 mg/.75g | GelTopical | Vertical Pharmaceuticals, LLC | 68025-083 | 68025-0083-0768025-0083-30 |
| Divigelestradiol | Estradiol .25 mg/.25g | GelTopical | Vertical Pharmaceuticals, LLC | 68025-065 | 68025-0065-0768025-0065-30 |
| Divigelestradiol | Estradiol .5 mg/.5g | GelTopical | Vertical Pharmaceuticals, LLC | 68025-066 | 68025-0066-0768025-0066-30 |
Other NDCs under NDA 022038
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Divigelestradiol | Estradiol .25 mg/.25g | GelTopical | Vertical Pharmaceuticals, LLC | 68025-065 |
| Divigelestradiol | Estradiol .5 mg/.5g | GelTopical | Vertical Pharmaceuticals, LLC | 68025-066 |
| Divigelestradiol | Estradiol .75 mg/.75g | GelTopical | Vertical Pharmaceuticals, LLC | 68025-083 |
| Divigelestradiol | Estradiol 1.25 mg/1.25g | GelTopical | Vertical Pharmaceuticals, LLC | 68025-086 |
| Estradiol | Estradiol .25 mg/.25g | GelTopical | Trigen Laboratories, LLC | 13811-090 |
| Estradiol | Estradiol .5 mg/.5g | GelTopical | Trigen Laboratories, LLC | 13811-091 |
| Estradiol | Estradiol .75 mg/.75g | GelTopical | Trigen Laboratories, LLC | 13811-092 |
| Estradiol | Estradiol 1 mg/g | GelTopical | Trigen Laboratories, LLC | 13811-093 |
| Estradiol | Estradiol 1.25 mg/1.25g | GelTopical | Trigen Laboratories, LLC | 13811-094 |