Prescription drug · ANDA
Microgestin 1.5/30 (norethindrone acetate/ethinyl estradiol) NDC 51862-872
Kit · Mayne Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51862-872-01 | 51862087201 | 1 BLISTER PACK in 1 PACKET (51862-872-01) / 1 KIT in 1 BLISTER PACKMarketed from Oct 11, 2020 | |
| 51862-872-02 | 51862087202 | 1 BLISTER PACK in 1 CARTON (51862-872-02) / 1 KIT in 1 BLISTER PACKMarketed from Oct 11, 2020 | |
| 51862-872-03 | 51862087203 | 3 BLISTER PACK in 1 CARTON (51862-872-03) / 1 KIT in 1 BLISTER PACKMarketed from Oct 11, 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 1.5/30
- Generic name (nonproprietary)
- norethindrone acetate/ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Mayne Pharma Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202996
- Marketing start
- Listing expires
- Identifiers
- Product ID 51862-872_b951b698-58e3-4a2a-a039-2589f6acf308SPL ID b951b698-58e3-4a2a-a039-2589f6acf308SPL set ID 9f49a476-596c-46e1-b67b-d3d40de84216RxCUI 1359022, 1359028, 1359032
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
N451862087201followed by a unit qualifier and the quantityPackage 51862-0872-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Microgestin 1.5/30 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 1 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.
Other NDCs under ANDA 202996
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 |
|---|---|---|---|---|
| Microgestin 1.5/30norethindrone acetate/ethinyl estradiol | — | Kit | Dr. Reddys Laboratories Inc. | 75907-083 |
| Larin 1.5/30norethindrone acetate/ethinyl estradiol | — | Kit | Northstar Rx LLC | 16714-407 |