Prescription drug · ANDA
Orquidea (norethindrone) NDC 70700-316
Norethindrone .35 mg/1 · Tablet · Oral · Xiromed, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-316-85 | 70700031685 | 3 POUCH in 1 CARTON (70700-316-85) / 1 BLISTER PACK in 1 POUCH (70700-316-84) / 28 TABLET in 1 BLISTER PACKMarketed from Jan 29, 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)
- Orquidea
- Generic name (nonproprietary)
- norethindrone
- Active ingredients
- Norethindrone — .35 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Xiromed, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201483
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 70700-316_a54bf859-7035-5948-0a50-9c42bb791c9fSPL ID a54bf859-7035-5948-0a50-9c42bb791c9fSPL set ID 6e9f61a1-93ff-291a-bea8-9307a3b0378eRxCUI 198042, 748961, 2704560UNII T18F433X4S
- Pharmacologic class
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470700031685followed by a unit qualifier and the quantityPackage 70700-0316-85. 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)
INDICATIONS AND USAGE 1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy. If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. Table 2: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. Emergency Contraceptive Pills: Treatment initia…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201483
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 |
|---|---|---|---|---|
| Norethindrone | Norethindrone .35 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-7292 |