Prescription drug · ANDA
Estradiol and Levonorgestrel NDC 70710-2169
Estradiol .045 mg/d; Levonorgestrel .015 mg/d · Patch · Transdermal · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-2169-8 | 7071021690870710216908 | 4 PATCH in 1 CARTON (70710-2169-8) / 7 d in 1 PATCH (70710-2169-1)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 Pharmaceuticals USA Inc.NDC labeler code 70710
- 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 70710-2169_ff28c70c-0323-43b0-83d7-1a2635a10193SPL ID ff28c70c-0323-43b0-83d7-1a2635a10193SPL set ID b143ebda-f5d7-4288-9a00-ba10a64f481fUNII 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
N470710216908followed by a unit qualifier and the quantityPackage 70710-2169-08. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Estradiol and Levonorgestrel Transdermal System is indicated for: Estradiol and Levonorgestrel Transdermal System is an estrogen plus progestin indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) Prevention of Postmenopausal Osteoporosis ( 1.2 ) Limitations of Use : When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for …
Excerpt only. Read the full label for complete information.
About NDC 70710-2169
- What is NDC 70710-2169?
- 70710-2169 is the product NDC for Estradiol and Levonorgestrel, Estradiol .045 mg/d; Levonorgestrel .015 mg/d patch, listed with the FDA by Zydus Pharmaceuticals USA Inc.. 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 Pharmaceuticals USA Inc., NDC labeler code 70710. 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 Lifesciences Limited | 70771-1992 |