NDC 0378-7316

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-7316Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-7316Add 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
0378-7316-85	00378731685	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.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206053
Marketing start: Oct 2, 2017
Listing expires: Dec 31, 2026
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

N400378731685 followed by a unit qualifier and the quantity

Package 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 May 31, 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 age 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 206053

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

FDA NDC Directory listings under ANDA 206053
Product	Strength	Form · route	Labeler	Product NDC
Rosyrahlevonorgestrel and ethinyl estradiol and ethinyl estradiol	—	KitOral	Xiromed, LLC	70700-312

Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol NDC 0378-7316