Prescription drug · ANDA
Estradiol / Norethindrone Acetate (Estradiol and norethindrone acetate) NDC 51991-474
Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 · Tablet, Film coated · Oral · Breckenridge Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51991-474-28 | 5199104742851991047428 | 1 BLISTER PACK in 1 CARTON (51991-474-28) / 28 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 17, 2008 |
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 / Norethindrone Acetate
- 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
- Breckenridge Pharmaceutical, Inc.NDC labeler code 51991
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078324
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 51991-474_d0f8f0e6-e2b1-40ff-8b4b-0ed8a7525689SPL ID d0f8f0e6-e2b1-40ff-8b4b-0ed8a7525689SPL set ID 44125b2f-10ac-435c-bdb4-a29bf8450dbfRxCUI 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
N451991047428followed by a unit qualifier and the quantityPackage 51991-0474-28. 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/Norethindrone Acetate Tablets are indicated for: Estradiol/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 c…
Excerpt only. Read the full label for complete information.
About NDC 51991-474
- What is NDC 51991-474?
- 51991-474 is the product NDC for Estradiol / Norethindrone Acetate, Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 tablet, film coated, listed with the FDA by Breckenridge Pharmaceutical, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Estradiol / Norethindrone Acetate (Estradiol and Norethindrone Acetate).
- What is the active ingredient?
- Estradiol, Norethindrone acetate.
- Who is the labeler?
- Breckenridge Pharmaceutical, Inc., NDC labeler code 51991. 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 / Norethindrone Acetate?
- 2 other product NDCs are listed under this name. See all Estradiol / 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 / 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 / Norethindrone Acetateestradiol and norethindrone acetate | Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 | Tablet, Film coatedOral | Breckenridge Pharmaceutical, Inc. | 51991-623 | 51991-0623-28 |
| Estradiol / Norethindrone Acetateestradiol and norethindrone acetate | Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8003 | 50090-8003-00 |
Other NDCs under ANDA 078324
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 / Norethindrone Acetateestradiol and norethindrone acetate | Estradiol 1 mg/1; Norethindrone acetate .5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8003 |
| Estradiol / Norethindrone Acetateestradiol and norethindrone acetate | Estradiol .5 mg/1; Norethindrone acetate .1 mg/1 | Tablet, Film coatedOral | Breckenridge Pharmaceutical, Inc. | 51991-623 |