Prescription drug · ANDA
norelgestromin and ethinyl estradiol NDC 70771-1777
Norelgestromin 150 ug/mg; Ethinyl estradiol 35 ug/mg · Patch · Transdermal · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1777-3 | 7077117770370771177703 | 3 POUCH in 1 CARTON (70771-1777-3) / 1 POUCH in 1 POUCH (70771-1777-1) / 7 mg in 1 POUCHMarketed from Nov 21, 2023 |
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)
- norelgestromin and ethinyl estradiol
- Generic name (nonproprietary)
- norelgestromin and ethinyl estradiol
- Active ingredients
- Norelgestromin — 150 ug/mgEthinyl estradiol — 35 ug/mg
- 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 214594
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 70771-1777_81ceed98-7fc6-416f-8787-08cbdd76a856SPL ID 81ceed98-7fc6-416f-8787-08cbdd76a856SPL set ID 7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a9RxCUI 1534809UNII R0TAY3X631, 423D2T571U
- Pharmacologic class
- Estrogen; Progestin
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
N470771177703followed by a unit qualifier and the quantityPackage 70771-1777-03. 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 70771-1777
- What is NDC 70771-1777?
- 70771-1777 is the product NDC for norelgestromin and ethinyl estradiol, Norelgestromin 150 ug/mg; Ethinyl estradiol 35 ug/mg 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?
- norelgestromin and ethinyl estradiol.
- What is the active ingredient?
- Norelgestromin, Ethinyl estradiol.
- 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 norelgestromin and ethinyl estradiol?
- 1 other product NDC are listed under this name. See all norelgestromin and ethinyl estradiol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other norelgestromin and ethinyl 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) |
|---|---|---|---|---|---|
| norelgestromin and ethinyl estradiol | Norelgestromin 150 ug/mg; Ethinyl estradiol 35 ug/mg | PatchTransdermal | Zydus Pharmaceuticals USA Inc. | 70710-1190 | 70710-1190-03 |
Other NDCs under ANDA 214594
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 |
|---|---|---|---|---|
| norelgestromin and ethinyl estradiol | Norelgestromin 150 ug/mg; Ethinyl estradiol 35 ug/mg | PatchTransdermal | Zydus Pharmaceuticals USA Inc. | 70710-1190 |