Amethyst NDC 0480-3472

NDC codes

FDA NDC Directory

Product NDC (as listed)0480-3472Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00480-3472Add 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
0480-3472-24	00480347224	1 POUCH in 1 CARTON (0480-3472-24) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACKMarketed from Mar 1, 2023

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): Amethyst
Generic name (nonproprietary): levonorgestrel and ethinyl estradiol
Active ingredients: Levonorgestrel — 90 ug/1Ethinyl estradiol — 20 ug/1
Dosage form: Tablet
Route: Oral
Labeler: Teva Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079218
Marketing start: Mar 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Estrogen Receptor Agonists (Mechanism)Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 0480-3472_e70f2946-fc53-487c-b37a-d11ee6751735SPL ID e70f2946-fc53-487c-b37a-d11ee6751735SPL set ID 99073fe0-eac8-44dd-abe6-623fa67d9e79RxCUI 722152, 751553, 1112715UNII 5W7SIA7YZW, 423D2T571U
Pharmacologic class: Estrogen; Progestin; Progestin-containing Intrauterine System

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400480347224 followed by a unit qualifier and the quantity

Package 00480-3472-24. 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 Jan 31, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Amethyst™ (levonorgestrel and ethinyl estradiol tablets) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)