Prescription drug · ANDA
Estradiol NDC 71335-0226
Estradiol .5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0226-1 | 71335022601 | 30 TABLET in 1 BOTTLE (71335-0226-1)Marketed from Jun 29, 2018 | |
| 71335-0226-2 | 71335022602 | 100 TABLET in 1 BOTTLE (71335-0226-2)Marketed from Dec 27, 2021 | |
| 71335-0226-3 | 71335022603 | 90 TABLET in 1 BOTTLE (71335-0226-3)Marketed from May 7, 2018 | |
| 71335-0226-4 | 71335022604 | 60 TABLET in 1 BOTTLE (71335-0226-4)Marketed from Dec 27, 2021 |
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
- Generic name (nonproprietary)
- estradiol
- Active ingredients
- Estradiol — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040275
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 71335-0226_4593e1f2-65b0-4a0f-ac69-0f2be718c63eSPL ID 4593e1f2-65b0-4a0f-ac69-0f2be718c63eSPL set ID fad3813c-9495-416b-9789-623d5758b4e3RxCUI 197657UNII 4TI98Z838E
- Pharmacologic class
- Estrogen
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
N471335022601followed by a unit qualifier and the quantityPackage 71335-0226-01. 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)
INDICATIONS AND USAGE Estradiol tablets are indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. 5. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). 6. Prevention …
Excerpt only. Read the full label for complete information.
About NDC 71335-0226
- What is NDC 71335-0226?
- 71335-0226 is the product NDC for Estradiol, Estradiol .5 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Estradiol.
- What is the active ingredient?
- Estradiol.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. 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?
- 181 other product NDCs are listed under this name. See all Estradiol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Estradiol 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 | Estradiol .75 mg/1.25g | GelTransdermal | Encube Ethicals, Inc. | 21922-015 | 21922-0015-40 |
| Estradiol | Estradiol .75 mg/1.25g | GelTopical | Solaris Pharma Corporation | 73473-308 | 73473-0308-50 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | Direct_Rx | 72189-655 | 72189-0655-60 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | Coupler LLC | 67046-1568 | 67046-1568-03 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | American Health Packaging | 60687-876 | 60687-0876-65 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8860 | 68788-8860-0168788-8860-0368788-8860-06+1 more |
| Estradiol | Estradiol .75 mg/1.25g | Gel, MeteredTopical | ANI Pharmaceuticals, Inc. | 70954-646 | 70954-0646-10 |
| Estradiolestradiol transdermal | Estradiol 1.25 mg/1.25g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2448 | 69238-2448-03 |
| Estradiolestradiol transdermal | Estradiol 1 mg/g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2449 | 69238-2449-03 |
| Estradiolestradiol transdermal | Estradiol .75 mg/.75g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2450 | 69238-2450-03 |
Other NDCs under ANDA 040275
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 | Estradiol .5 mg/1 | TabletOral | PURACAP LABORATORIES, LLC | 24658-702 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | PURACAP LABORATORIES, LLC | 24658-703 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | PURACAP LABORATORIES, LLC | 24658-704 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | EPIC PHARMA, LLC | 42806-087 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | EPIC PHARMA, LLC | 42806-088 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | EPIC PHARMA, LLC | 42806-089 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5494 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-6359 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-6363 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-7452 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-860 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-4788 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3394 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4485 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7102 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2829 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3818 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0797 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | Direct_Rx | 72189-502 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | Direct_Rx | 72189-508 |
Showing 20 of 23.