Prescription drug · ANDA
Microgestin Fe 1/20 NDC 51862-866
norethindrone acetate/ethinyl estradiol and ferrous fumarate · Kit · Mayne Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51862-866-01 | 5186208660151862086601 | 1 BLISTER PACK in 1 PACKET (51862-866-01) / 1 KIT in 1 BLISTER PACKMarketed from Oct 12, 2020 | |
| 51862-866-02 | 5186208660251862086602 | 1 BLISTER PACK in 1 CARTON (51862-866-02) / 1 KIT in 1 BLISTER PACKMarketed from Oct 12, 2020 | |
| 51862-866-03 | 5186208660351862086603 | 3 BLISTER PACK in 1 CARTON (51862-866-03) / 1 KIT in 1 BLISTER PACKMarketed from Oct 12, 2020 |
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 Fe 1/20
- Generic name (nonproprietary)
- norethindrone acetate/ethinyl estradiol and ferrous fumarate
- Dosage form
- Kit
- Labeler
- Mayne Pharma Inc.NDC labeler code 51862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091454
- Marketing start
- Listing expires
- Identifiers
- Product ID 51862-866_4a96e2db-df35-412f-b869-930085475574SPL ID 4a96e2db-df35-412f-b869-930085475574SPL set ID 5bf28e22-8f58-4166-8a62-2717ecd6a70fRxCUI 259176, 1358762, 1358763, 1358775
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
N451862086601followed by a unit qualifier and the quantityPackage 51862-0866-01. 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 Microgestin Fe 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. 2
Excerpt only. Read the full label for complete information.
About NDC 51862-866
- What is NDC 51862-866?
- 51862-866 is the product NDC for Microgestin Fe 1/20 kit, listed with the FDA by Mayne Pharma Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Microgestin Fe 1/20 (Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate).
- Who is the labeler?
- Mayne Pharma Inc., NDC labeler code 51862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Microgestin Fe 1/20?
- 1 other product NDC are listed under this name. See all Microgestin Fe 1/20 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Microgestin Fe 1/20 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Microgestin Fe 1/20norethindrone acetate/ethinyl estradiol and ferrous fumarate | — | Kit | Dr. Reddy's Laboratories Inc. | 75907-082 | 75907-0082-2875907-0082-62 |
Other NDCs under ANDA 091454
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 Fe 1/20norethindrone acetate/ethinyl estradiol and ferrous fumarate | — | Kit | Northstar Rx LLC | 16714-406 |
| Microgestin Fe 1/20norethindrone acetate/ethinyl estradiol and ferrous fumarate | — | Kit | Dr. Reddy's Laboratories Inc. | 75907-082 |