Prescription drug · NDA AUTHORIZED GENERIC
medroxyprogesterone acetate NDC 59762-0058
Medroxyprogesterone acetate 5 mg/1 · Tablet · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59762-0058-1 | 5976200580159762005801 | 100 TABLET in 1 BOTTLE (59762-0058-1)Marketed from Jan 2, 2019 | |
| 59762-0058-2 | 5976200580259762005802 | 1000 TABLET in 1 BOTTLE (59762-0058-2)Marketed from May 11, 2020 |
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)
- medroxyprogesterone acetate
- Generic name (nonproprietary)
- medroxyprogesterone acetate
- Active ingredients
- Medroxyprogesterone acetate — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 59762
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 011839
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 59762-0058_602a8237-8197-41ce-bfaf-03c6340cbe07SPL ID 602a8237-8197-41ce-bfaf-03c6340cbe07SPL set ID 2627eb11-06bf-4a45-9172-094468e3ca07RxCUI 1000114, 1000135, 1000141UNII C2QI4IOI2GUPC 0359762005618, 0359762005519
- Pharmacologic class
- 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
N459762005801followed by a unit qualifier and the quantityPackage 59762-0058-01. 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 Medroxyprogesterone acetate tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.
Excerpt only. Read the full label for complete information.
About NDC 59762-0058
- What is NDC 59762-0058?
- 59762-0058 is the product NDC for medroxyprogesterone acetate, Medroxyprogesterone acetate 5 mg/1 tablet, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- medroxyprogesterone acetate.
- What is the active ingredient?
- Medroxyprogesterone acetate.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 59762. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for medroxyprogesterone acetate?
- 39 other product NDCs are listed under this name. See all medroxyprogesterone acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other medroxyprogesterone 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) |
|---|---|---|---|---|---|
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 2.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4666 | 70518-4666-0070518-4666-02 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 150 mg/mL | Injection, SuspensionIntramuscular | Amneal Pharmaceuticals NY LLC | 60219-1467 | 60219-1467-0160219-1467-02 |
| medroxyprogesterone acetate | Medroxyprogesterone acetate 150 mg/mL | Injection, SuspensionIntramuscular | REMEDYREPACK INC. | 70518-4324 | 70518-4324-00 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 2.5 mg/1 | TabletOral | Coupler LLC | 67046-1480 | 67046-1480-03 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 150 mg/mL | Injection, SuspensionIntramuscular | Xiromed LLC | 70700-315 | 70700-0315-2570700-0315-27 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-520 | 51655-0520-52 |
| medroxyprogesterone acetate | Medroxyprogesterone acetate 150 mg/mL | Injection, SuspensionIntramuscular | Amneal Pharmaceuticals LLC | 70121-1467 | 70121-1467-0270121-1467-05 |
| medroxyprogesterone acetate | Medroxyprogesterone acetate 150 mg/mL | Injection, SuspensionIntramuscular | Amneal Pharmaceuticals LLC | 70121-1480 | 70121-1480-01 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 150 mg/mL | Injection, SuspensionIntramuscular | Eugia US LLC | 55150-330 | 55150-0330-01 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 150 mg/mL | Injection, SuspensionIntramuscular | Eugia US LLC | 55150-329 | 55150-0329-0155150-0329-25 |
Other NDCs under NDA 011839
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 |
|---|---|---|---|---|
| medroxyprogesterone acetate | Medroxyprogesterone acetate 2.5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-0055 |
| medroxyprogesterone acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-0056 |
| Proveramedroxyprogesterone acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | Pharmacia & Upjohn Company LLC | 0009-0051 |
| Proveramedroxyprogesterone acetate | Medroxyprogesterone acetate 2.5 mg/1 | TabletOral | Pharmacia & Upjohn Company LLC | 0009-0065 |
| Proveramedroxyprogesterone acetate | Medroxyprogesterone acetate 5 mg/1 | TabletOral | Pharmacia & Upjohn Company LLC | 0009-0287 |