Prescription drug · ANDA
Microgestin 1.5/30 (Norethindrone acetate/ethinyl estradiol) NDC 75907-083
Kit · Dr. Reddys Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75907-083-21 | 7590700832175907008321 | 1 BLISTER PACK in 1 PACKET (75907-083-21) / 1 KIT in 1 BLISTER PACKMarketed from May 1, 2024 | |
| 75907-083-63 | 7590700836375907008363 | 6 BLISTER PACK in 1 CARTON (75907-083-63) / 1 KIT in 1 BLISTER PACKMarketed from May 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 1.5/30
- Generic name (nonproprietary)
- norethindrone acetate/ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Dr. Reddys Laboratories Inc.NDC labeler code 75907
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202996
- Marketing start
- Listing expires
- Identifiers
- Product ID 75907-083_5a4e451f-3d3e-4624-88b1-f40be96f2656SPL ID 5a4e451f-3d3e-4624-88b1-f40be96f2656SPL set ID 6848575e-39d8-418b-ac38-ca2793f6f367RxCUI 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
N475907008321followed by a unit qualifier and the quantityPackage 75907-0083-21. 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 1.5/30 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 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. table1
Excerpt only. Read the full label for complete information.
About NDC 75907-083
- What is NDC 75907-083?
- 75907-083 is the product NDC for Microgestin 1.5/30 (norethindrone acetate/ethinyl estradiol) kit, listed with the FDA by Dr. Reddys Laboratories Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Microgestin 1.5/30 (Norethindrone Acetate/Ethinyl Estradiol).
- Who is the labeler?
- Dr. Reddys Laboratories 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 Microgestin 1.5/30?
- 1 other product NDC are listed under this name. See all Microgestin 1.5/30 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Microgestin 1.5/30 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 1.5/30norethindrone acetate/ethinyl estradiol | — | Kit | Mayne Pharma Inc. | 51862-872 | 51862-0872-0151862-0872-0251862-0872-03 |
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 |
|---|---|---|---|---|
| Larin 1.5/30norethindrone acetate/ethinyl estradiol | — | Kit | Northstar Rx LLC | 16714-407 |
| Microgestin 1.5/30norethindrone acetate/ethinyl estradiol | — | Kit | Mayne Pharma Inc. | 51862-872 |