Ethynodiol Diacetate And Ethinyl Estradiol NDC 0378-7307

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-7307Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-7307Add 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
0378-7307-53	00378730753	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.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204703
Marketing start: Sep 19, 2017
Listing expires: Dec 31, 2026
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

N400378730753 followed by a unit qualifier and the quantity

Package 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 Dec 16, 2021. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204703

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

FDA NDC Directory listings under ANDA 204703
Product	Strength	Form · route	Labeler	Product NDC
Valtya 1/35ethynodiol diacetate and ethinyl estradiol	—	Kit	Xiromed LLC	70700-304