What is NDC 0093-5455?

0093-5455 is the product NDC for Mimvey, Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Mimvey (Estradiol and Norethindrone Acetate).

What is the active ingredient?

Estradiol, Norethindrone acetate.

Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Mimvey?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Mimvey NDC 0093-5455 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0093-5455Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00093-5455Add 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
0093-5455-28	0009354552800093545528	1 BLISTER PACK in 1 CARTON (0093-5455-28) / 28 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 2, 2010
0093-5455-42	0009354554200093545542	5 BLISTER PACK in 1 CARTON (0093-5455-42) / 28 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 2, 2010

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): Mimvey
Generic name (nonproprietary): estradiol and norethindrone acetate
Active ingredients: Estradiol — 1 mg/1Norethindrone acetate — .5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079193
Marketing start: Jun 2, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 0093-5455_2704fcb9-da21-461e-b6ba-b196b2f2bf4bSPL ID 2704fcb9-da21-461e-b6ba-b196b2f2bf4bSPL set ID b1c5c06b-9ce2-4bf7-9693-e37608055a14RxCUI 1359126, 1359127, 1359129UNII 4TI98Z838E, 9S44LIC7OJ
Pharmacologic class: Estrogen; Progestin

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

N400093545528 followed by a unit qualifier and the quantity

Package 00093-5455-28. 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, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Mimvey is indicated for: Mimvey is an estrogen and progestin combination indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) Limitations of Use: When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products. Prevention of Postmenopausal Osteoporosis ( 1.3 ) Limitations of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0093-5455

What is NDC 0093-5455?: 0093-5455 is the product NDC for Mimvey, Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Mimvey (Estradiol and Norethindrone Acetate).
What is the active ingredient?: Estradiol, Norethindrone acetate.
Who is the labeler?: Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mimvey?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Mimvey (Estradiol and norethindrone acetate) NDC 0093-5455