Prescription drug · ANDA
Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol NDC 0378-7296
Kit · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-7296-53 | 0037872965300378729653 | 3 POUCH in 1 CARTON (0378-7296-53) / 1 BLISTER PACK in 1 POUCH (0378-7296-85) / 1 KIT in 1 BLISTER PACKMarketed from Jul 16, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol
- Generic name (nonproprietary)
- desogestrel and ethinyl estradiol and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202296
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-7296_72beb662-5600-1ec5-724c-9ff5b4254e0fSPL ID 72beb662-5600-1ec5-724c-9ff5b4254e0fSPL set ID 142c4b90-c9ab-45ce-9172-f1ea7d366686RxCUI 248310, 249357, 748797, 759743
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
N400378729653followed by a unit qualifier and the quantityPackage 00378-7296-53. 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 Desogestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II 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 these methods can result in lower failure rates. TABLE II: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE F…
Excerpt only. Read the full label for complete information.
About NDC 0378-7296
- What is NDC 0378-7296?
- 0378-7296 is the product NDC for Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol kit, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol?
- 1 other product NDC are listed under this name. See all Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| desogestrel and ethinyl estradiol and ethinyl estradiol | — | Kit | Naari Pte. Limited | 79929-020 | 79929-0020-07 |