Prescription drug · ANDA
Estradiol and Norethindrone Acetate NDC 50090-8004
Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-8004-0 | 5009080040050090800400 | 1 BLISTER PACK in 1 CARTON (50090-8004-0) / 28 TABLET in 1 BLISTER PACKMarketed from Jun 25, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — .5 mg/1Norethindrone acetate — .1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- 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 50090-8004_c446c7b6-aa56-45e7-bb47-5ce71a614719SPL ID c446c7b6-aa56-45e7-bb47-5ce71a614719SPL set ID 1521007a-546d-421e-99e1-e10d90c0b090RxCUI 1359123, 1359124UNII 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
N450090800400followed by a unit qualifier and the quantityPackage 50090-8004-00. 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.
About NDC 50090-8004
- What is NDC 50090-8004?
- 50090-8004 is the product NDC for Estradiol and Norethindrone Acetate, Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 tablet, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, 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?
- A-S Medication Solutions, NDC labeler code 50090. 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.
Related NDCs: other Estradiol and Norethindrone Acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Estradiol And Norethindrone Acetate | Norethindrone acetate .5 mg/1; Estradiol 1 mg/1 | TabletOral | Naari Pte. Limited | 79929-012 | 79929-0012-07 |
| Estradiol and Norethindrone Acetate | Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 | TabletOral | Ingenus Pharmaceuticals, LLC | 50742-657 | 50742-0657-2850742-0657-6850742-0657-84 |
| Estradiol and Norethindrone Acetate | Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 | TabletOral | Ingenus Pharmaceuticals, LLC | 50742-658 | 50742-0658-2850742-0658-6850742-0658-84 |
Other NDCs under ANDA 210612
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Estradiol and Norethindrone Acetate | Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 | TabletOral | Ingenus Pharmaceuticals, LLC | 50742-657 |
| Estradiol and Norethindrone Acetate | Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 | TabletOral | Ingenus Pharmaceuticals, LLC | 50742-658 |