What is NDC 0378-7287?

0378-7287 is the product NDC for Levonorgestrel 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.

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?

8 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Levonorgestrel And Ethinyl Estradiol NDC 0378-7287

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-7287Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-7287Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0378-7287-53	0037872875300378728753	3 POUCH in 1 CARTON (0378-7287-53) / 1 BLISTER PACK in 1 POUCH (0378-7287-85) / 1 KIT in 1 BLISTER PACKMarketed from Jun 26, 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): Levonorgestrel And Ethinyl Estradiol
Generic name (nonproprietary): levonorgestrel 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 200245
Marketing start: Jun 26, 2014
Listing expires: Dec 31, 2026
Identifiers: Product ID 0378-7287_f7eda601-d51e-ab22-99a9-2f1551d96293SPL ID f7eda601-d51e-ab22-99a9-2f1551d96293SPL set ID c3c00dc0-8834-45fb-9f5b-810a98cef59dRxCUI 242297, 748797, 748868

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

N400378728753 followed by a unit qualifier and the quantity

Package 00378-7287-53. 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 Aug 31, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Levonorgestrel and ethinyl estradiol tablets 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 2 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, the IUD, and Norplant ® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 2: Percentage of Women Experiencing An Unintended Pregnancy During The First Year Of Typical Use And T…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-7287

What is NDC 0378-7287?: 0378-7287 is the product NDC for Levonorgestrel 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.
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?: 8 other product NDCs are listed under this name. See all Levonorgestrel And Ethinyl Estradiol NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Levonorgestrel And Ethinyl Estradiol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Levonorgestrel and Ethinyl Estradiol	—	Kit	Naari Pte Limited	79929-004	79929-0004-07
levonorgestrel and ethinyl estradiol	—	Kit	Acella Pharmaceuticals	42192-623	42192-0623-0342192-0623-28
Levonorgestrel and Ethinyl Estradiol	—	Kit	Naari Pte Limited	79929-003	79929-0003-07
Levonorgestrel and Ethinyl Estradiol	—	Kit	Lupin Pharmaceuticals, Inc.	68180-857	68180-0857-73
Levonorgestrel and Ethinyl Estradiol	—	Kit	Lupin Pharmaceuticals, Inc.	68180-854	68180-0854-73
levonorgestrel and ethinyl estradiol	—	Kit	Glenmark Pharmaceuticals Inc., USA	68462-672	68462-0672-95
Levonorgestrel and Ethinyl Estradiol	Levonorgestrel 90 ug/1; Ethinyl estradiol 20 ug/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-637	68462-0637-29
Levonorgestrel and Ethinyl Estradiol	—	Kit	Lupin Pharmaceuticals, Inc.	68180-843	68180-0843-1368180-0843-73