Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol NDC 0378-7284

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-7284Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-7284Add 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
0378-7284-90	00378728490	2 POUCH in 1 CARTON (0378-7284-90) / 1 BLISTER PACK in 1 POUCH (0378-7284-85) / 1 KIT in 1 BLISTER PACKMarketed from Nov 7, 2016

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.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200493
Marketing start: Nov 7, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 0378-7284_acdbfefa-665e-f20d-7ea4-781a63f6a171SPL ID acdbfefa-665e-f20d-7ea4-781a63f6a171SPL set ID ada28708-ab65-4c07-a695-9141c5ce26bcRxCUI 242297, 248310, 810096UPC 0303787284855

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

N400378728490 followed by a unit qualifier and the quantity

Package 00378-7284-90. 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 Apr 20, 2023. 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 potential to prevent pregnancy.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200493

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 200493
Product	Strength	Form · route	Labeler	Product NDC
Lojaimiesslevonorgestrel and ethinyl estradiol and ethinyl estradiol tablets	—	Kit	Xiromed LLC	70700-207