Prescription drug · ANDA
Estradiol Gel (Estradiol) NDC 21922-087
Estradiol .5 mg/.5g · Gel · Topical · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-087-52 | 21922008752 | 30 PACKET in 1 CARTON (21922-087-52) / .5 g in 1 PACKETMarketed from Mar 10, 2025 |
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 Gel
- Generic name (nonproprietary)
- estradiol
- Active ingredients
- Estradiol — .5 mg/.5g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Encube Ethicals, Inc.NDC labeler code 21922
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218507
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 21922-087_5390c5ff-21e0-4b69-9e88-5593dbcbd9feSPL ID 5390c5ff-21e0-4b69-9e88-5593dbcbd9feSPL set ID d4a3606f-83b2-45df-bc77-faebfa796f9aRxCUI 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
N421922008752followed by a unit qualifier and the quantityPackage 21922-0087-52. 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 0.1% 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 21922-087
- What is NDC 21922-087?
- 21922-087 is the product NDC for Estradiol Gel (estradiol), Estradiol .5 mg/.5g gel, listed with the FDA by Encube Ethicals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Estradiol Gel (Estradiol).
- What is the active ingredient?
- Estradiol.
- Who is the labeler?
- Encube Ethicals, Inc., NDC labeler code 21922. 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 Gel?
- 4 other product NDCs are listed under this name. See all Estradiol Gel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Estradiol Gel 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 Gelestradiol | Estradiol .25 mg/.25g | GelTopical | Encube Ethicals, Inc. | 21922-086 | 21922-0086-52 |
| Estradiol Gelestradiol | Estradiol .75 mg/.75g | GelTopical | Encube Ethicals, Inc. | 21922-088 | 21922-0088-52 |
| Estradiol Gelestradiol | Estradiol 1 mg/g | GelTopical | Encube Ethicals, Inc. | 21922-089 | 21922-0089-52 |
| Estradiol Gelestradiol | Estradiol 1.25 mg/1.25g | GelTopical | Encube Ethicals, Inc. | 21922-090 | 21922-0090-52 |
Other NDCs under ANDA 218507
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 |
|---|---|---|---|---|
| Estradiol Gelestradiol | Estradiol .25 mg/.25g | GelTopical | Encube Ethicals, Inc. | 21922-086 |
| Estradiol Gelestradiol | Estradiol 1.25 mg/1.25g | GelTopical | Encube Ethicals, Inc. | 21922-090 |
| Estradiol Gelestradiol | Estradiol .75 mg/.75g | GelTopical | Encube Ethicals, Inc. | 21922-088 |
| Estradiol Gelestradiol | Estradiol 1 mg/g | GelTopical | Encube Ethicals, Inc. | 21922-089 |