Prescription drug · ANDA
Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol NDC 0378-7316
Kit · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-7316-85 | 0037873168500378731685 | 1 POUCH in 1 CARTON (0378-7316-85) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Oct 2, 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)
- Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol
- Generic name (nonproprietary)
- levonorgestrel 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 206053
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-7316_ec0afe77-8394-9a0d-61c5-e2522c725ad9SPL ID ec0afe77-8394-9a0d-61c5-e2522c725ad9SPL set ID 5c1d0a3a-1b24-44a0-9c53-224365b65945RxCUI 238019, 248310, 1373501, 1373502, 1373503
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
N400378731685followed by a unit qualifier and the quantityPackage 00378-7316-85. 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)
Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for use by females of reproductive age to prevent pregnancy.
Excerpt only. Read the full label for complete information.
About NDC 0378-7316
- What is NDC 0378-7316?
- 0378-7316 is the product NDC for Levonorgestrel 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?
- Levonorgestrel 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 Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol?
- 2 other product NDCs are listed under this name. See all Levonorgestrel 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 Levonorgestrel 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) |
|---|---|---|---|---|---|
| Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol | — | Kit | Mylan Pharmaceuticals Inc. | 0378-7284 | 00378-7284-90 |
| Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiollevonorgestrel and ethinyl estradiol | — | Kit | Lupin Pharmaceuticals, Inc. | 68180-848 | 68180-0848-13 |
Other NDCs under ANDA 206053
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 |
|---|---|---|---|---|
| Rosyrahlevonorgestrel and ethinyl estradiol and ethinyl estradiol | — | KitOral | Xiromed, LLC | 70700-312 |