Prescription drug · NDA
Estradiol NDC 13811-093
Estradiol 1 mg/g · Gel · Topical · Trigen Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13811-093-32 | 1381100933213811009332 | 30 PACKET in 1 CARTON (13811-093-32) / 1 g in 1 PACKETMarketed from Oct 10, 2022 | |
| 13811-093-92 | 1381100939213811009392 | 90 PACKET in 1 CARTON (13811-093-92) / 1 g in 1 PACKETMarketed from Aug 20, 2026 |
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/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Trigen Laboratories, LLCNDC labeler code 13811
- 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 13811-093_61e9402a-ea30-4199-9295-ba6e185d1e83SPL ID 61e9402a-ea30-4199-9295-ba6e185d1e83SPL set ID e84ad638-6768-41aa-b2b8-e2514ef63881RxCUI 2619677, 2619679, 2619681, 2619683, 2619685UNII 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
N413811009332followed by a unit qualifier and the quantityPackage 13811-0093-32. 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)
Estradiol gel 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 13811-093
- What is NDC 13811-093?
- 13811-093 is the product NDC for Estradiol, Estradiol 1 mg/g gel, listed with the FDA by Trigen Laboratories, LLC. It has 2 package NDCs, 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?
- Trigen Laboratories, LLC, NDC labeler code 13811. 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.
Related NDCs: other Estradiol products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
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 1 mg/g | GelTopical | Vertical Pharmaceuticals, LLC | 68025-067 |
| 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 1.25 mg/1.25g | GelTopical | Trigen Laboratories, LLC | 13811-094 |