Prescription drug · ANDA
Estradiol and Levonorgestrel NDC 70771-1992
Estradiol .045 mg/d; Levonorgestrel .015 mg/d · Patch · Transdermal · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1992-8 | 7077119920870771199208 | 4 PATCH in 1 CARTON (70771-1992-8) / 7 d in 1 PATCH (70771-1992-1)Marketed from Nov 10, 2026 |
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 and Levonorgestrel
- Generic name (nonproprietary)
- estradiol and levonorgestrel
- Active ingredients
- Estradiol — .045 mg/dLevonorgestrel — .015 mg/d
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220407
- Marketing start
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 70771-1992_d1e8984e-6448-47df-91a3-7e41cdf6e01fSPL ID d1e8984e-6448-47df-91a3-7e41cdf6e01fSPL set ID 3fb00f13-d8b3-4391-9548-6ee912b2b5aaUNII 4TI98Z838E, 5W7SIA7YZW
- Pharmacologic class
- Estrogen; Progestin; Progestin-containing Intrauterine System
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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470771199208followed by a unit qualifier and the quantityPackage 70771-1992-08. 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 .
About NDC 70771-1992
- What is NDC 70771-1992?
- 70771-1992 is the product NDC for Estradiol and Levonorgestrel, Estradiol .045 mg/d; Levonorgestrel .015 mg/d patch, listed with the FDA by Zydus Lifesciences Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Estradiol and Levonorgestrel.
- What is the active ingredient?
- Estradiol, Levonorgestrel.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 70771. 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 and Levonorgestrel?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 220407
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 and Levonorgestrel | Estradiol .045 mg/d; Levonorgestrel .015 mg/d | PatchTransdermal | Zydus Pharmaceuticals USA Inc. | 70710-2169 |