Prescription drug · ANDA
Medroxyprogesterone Acetate NDC 0555-0873
Medroxyprogesterone acetate 5 mg/1 · Tablet · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0555-0873-02 | 0055508730200555087302 | 100 TABLET in 1 BOTTLE (0555-0873-02)Marketed from Dec 4, 1996 | |
| 0555-0873-04 | 0055508730400555087304 | 500 TABLET in 1 BOTTLE (0555-0873-04)Marketed from Dec 4, 1996 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Medroxyprogesterone Acetate
- Generic name (nonproprietary)
- medroxyprogesterone acetate
- Active ingredients
- Medroxyprogesterone acetate — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0555
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040159
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 0555-0873_b8f519a9-a8d0-4dd5-b138-564fb579c461SPL ID b8f519a9-a8d0-4dd5-b138-564fb579c461SPL set ID 9eb200b0-db96-4a51-87ea-04db862978c8RxCUI 1000114, 1000135, 1000141UNII C2QI4IOI2GUPC 0305550873020, 0305550872023
- 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
N400555087302followed by a unit qualifier and the quantityPackage 00555-0873-02. 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, USP 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 0555-0873
- What is NDC 0555-0873?
- 0555-0873 is the product NDC for Medroxyprogesterone Acetate, Medroxyprogesterone acetate 5 mg/1 tablet, listed with the FDA by Teva Pharmaceuticals USA, 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?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. 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 ANDA 040159
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 | PD-Rx Pharmaceuticals, Inc. | 72789-043 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-0166 |
| Medroxyprogesterone | Medroxyprogesterone acetate 10 mg/1 | TabletOral | PharmPak, Inc. | 54348-805 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 55289-160 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9899 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4132 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 2.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-0490 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-0491 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 2.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4666 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2612 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8825 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8824 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8826 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 2.5 mg/1 | TabletOral | Coupler LLC | 67046-1480 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0555-0779 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3070 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8112 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 2.5 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0555-0872 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-520 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4777 |
Showing 20 of 22.