Prescription drug · ANDA
Errin (Norethindrone) NDC 75907-075
Norethindrone .35 mg/1 · Tablet · Oral · Dr. Reddy's Labratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75907-075-32 | 75907007532 | 3 BLISTER PACK in 1 CARTON (75907-075-32) / 28 TABLET in 1 BLISTER PACK (75907-075-28)Marketed from Mar 10, 2024 |
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)
- Errin
- Generic name (nonproprietary)
- norethindrone
- Active ingredients
- Norethindrone — .35 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Dr. Reddy's Labratories Inc.NDC labeler code 75907
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076225
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 75907-075_6615e1eb-0743-b33f-0119-00f5d7ab97b6SPL ID 6615e1eb-0743-b33f-0119-00f5d7ab97b6SPL set ID df29577b-c2f0-bea8-b048-7719972707aaRxCUI 198042, 748961, 831533UNII 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
N475907007532followed by a unit qualifier and the quantityPackage 75907-0075-32. 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 .
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 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception. Table 1: 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. % of Women Experiencing an Unintended Pregnancy within the Fi…
Excerpt only. Read the full label for complete information.
About NDC 75907-075
- What is NDC 75907-075?
- 75907-075 is the product NDC for Errin (norethindrone), Norethindrone .35 mg/1 tablet, listed with the FDA by Dr. Reddy's Labratories Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Errin (Norethindrone).
- What is the active ingredient?
- Norethindrone.
- Who is the labeler?
- Dr. Reddy's Labratories Inc., NDC labeler code 75907. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Errin?
- 1 other product NDC are listed under this name. See all Errin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Errin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Errinnorethindrone | Norethindrone .35 mg/1 | TabletOral | Proficient Rx LP | 71205-526 | 71205-0526-28 |
Other NDCs under ANDA 076225
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 |
|---|---|---|---|---|
| Errinnorethindrone | Norethindrone .35 mg/1 | TabletOral | Proficient Rx LP | 71205-526 |