Prescription drug · ANDA
Microgestin 1/20 (norethindrone acetate/ethinyl estradiol) NDC 75907-084
Kit · Dr.Reddy's Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75907-084-21 | 75907008421 | 1 BLISTER PACK in 1 PACKET (75907-084-21) / 1 KIT in 1 BLISTER PACKMarketed from Jun 1, 2024 | |
| 75907-084-63 | 75907008463 | 6 BLISTER PACK in 1 CARTON (75907-084-63) / 1 KIT in 1 BLISTER PACKMarketed from Jun 1, 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)
- Microgestin 1/20
- Generic name (nonproprietary)
- norethindrone acetate/ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Dr.Reddy's Laboratories Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202995
- Marketing start
- Listing expires
- Identifiers
- Product ID 75907-084_525021a6-a904-4601-8427-d967e774762aSPL ID 525021a6-a904-4601-8427-d967e774762aSPL set ID 8754135b-5a8e-4cc1-a66c-c2f6a3c90005RxCUI 1358762, 1358776, 1359020
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N475907008421followed by a unit qualifier and the quantityPackage 75907-0084-21. 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 Microgestin 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE 1
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202995
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 |
|---|---|---|---|---|
| Larin 1/20norethindrone acetate/ethinyl estradiol | — | Kit | Northstar Rx LLC | 16714-408 |
| Microgestin 1/20norethindrone acetate/ethinyl estradiol | — | Kit | Mayne Pharma Inc. | 51862-868 |