NDC codes

FDA NDC Directory
Product NDC (as listed)50742-657Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50742-0657Add 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 NDC11-digit (billing)PackageCopy
50742-657-2850742065728507420657281 BLISTER PACK in 1 CARTON (50742-657-28) / 28 TABLET in 1 BLISTER PACKMarketed from Apr 3, 2019
50742-657-6850742065768507420657686 BLISTER PACK in 1 CARTON (50742-657-68) / 28 TABLET in 1 BLISTER PACKMarketed from Apr 3, 2019
50742-657-8450742065784507420657843 BLISTER PACK in 1 CARTON (50742-657-84) / 28 TABLET in 1 BLISTER PACKMarketed from Apr 3, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Estradiol and Norethindrone Acetate
Generic name (nonproprietary)
estradiol and norethindrone acetate
Active ingredients
Estradiol — 1 mg/1Norethindrone acetate — .5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Ingenus Pharmaceuticals, LLCNDC labeler code 50742
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210612
Marketing start
Listing expires
Other FDA classes
Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers
Product ID 50742-657_b156b1fa-c3f8-42fd-a8e3-e1f9c58e0175SPL ID b156b1fa-c3f8-42fd-a8e3-e1f9c58e0175SPL set ID 50c786d6-91bd-4eea-9455-ff2abc08372fRxCUI 1359123, 1359124, 1359126, 1359127UNII 9S44LIC7OJ, 4TI98Z838E
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

N450742065728 followed by a unit qualifier and the quantity

Package 50742-0657-28. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Estradiol and norethindrone acetate tablets are 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 est…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50742-657

What is NDC 50742-657?
50742-657 is the product NDC for Estradiol and Norethindrone Acetate, Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 tablet, listed with the FDA by Ingenus Pharmaceuticals, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Estradiol and Norethindrone Acetate.
What is the active ingredient?
Estradiol, Norethindrone acetate.
Who is the labeler?
Ingenus Pharmaceuticals, LLC, NDC labeler code 50742. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Estradiol and Norethindrone Acetate?
3 other product NDCs are listed under this name. See all Estradiol and Norethindrone Acetate NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Estradiol and Norethindrone Acetate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Estradiol And Norethindrone AcetateNorethindrone acetate .5 mg/1; Estradiol 1 mg/1TabletOralNaari Pte. Limited79929-01279929-0012-07
Estradiol and Norethindrone AcetateEstradiol .5 mg/1; Norethindrone acetate .1 mg/1TabletOralA-S Medication Solutions50090-800450090-8004-00
Estradiol and Norethindrone AcetateEstradiol .5 mg/1; Norethindrone acetate .1 mg/1TabletOralIngenus Pharmaceuticals, LLC50742-65850742-0658-2850742-0658-6850742-0658-84

Other NDCs under ANDA 210612

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

FDA NDC Directory listings under ANDA 210612
ProductStrengthForm · routeLabelerProduct NDC
Estradiol and Norethindrone AcetateEstradiol .5 mg/1; Norethindrone acetate .1 mg/1TabletOralA-S Medication Solutions50090-8004
Estradiol and Norethindrone AcetateEstradiol .5 mg/1; Norethindrone acetate .1 mg/1TabletOralIngenus Pharmaceuticals, LLC50742-658

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