Prescription drug · ANDA
Ethynodiol Diacetate And Ethinyl Estradiol NDC 0378-7307
Kit · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-7307-53 | 0037873075300378730753 | 3 POUCH in 1 CARTON (0378-7307-53) / 1 BLISTER PACK in 1 POUCH (0378-7307-85) / 1 KIT in 1 BLISTER PACKMarketed from Sep 19, 2017 |
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)
- Ethynodiol Diacetate And Ethinyl Estradiol
- Generic name (nonproprietary)
- ethynodiol diacetate 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 204703
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-7307_58682d4f-d934-69bc-92e4-9033e1425b47SPL ID 58682d4f-d934-69bc-92e4-9033e1425b47SPL set ID 47263647-a9ac-40e4-83c0-d6500fa458cdRxCUI 310228, 748797, 748804
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
N400378730753followed by a unit qualifier and the quantityPackage 00378-7307-53. 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 Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg are 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 and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 1. Percentage of women experiencing an unintended pregnancy during the …
Excerpt only. Read the full label for complete information.
About NDC 0378-7307
- What is NDC 0378-7307?
- 0378-7307 is the product NDC for Ethynodiol Diacetate 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?
- Ethynodiol Diacetate 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 Ethynodiol Diacetate And Ethinyl Estradiol?
- 1 other product NDC are listed under this name. See all Ethynodiol Diacetate 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 Ethynodiol Diacetate 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) |
|---|---|---|---|---|---|
| Ethynodiol Diacetate And Ethinyl Estradiol | — | Kit | Mylan Pharmaceuticals Inc. | 0378-7306 | 00378-7306-53 |
Other NDCs under ANDA 204703
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 |
|---|---|---|---|---|
| Valtya 1/35ethynodiol diacetate and ethinyl estradiol | — | Kit | Xiromed LLC | 70700-304 |