Prescription drug · ANDA
Medroxyprogesterone Acetate NDC 72789-043
Medroxyprogesterone acetate 2.5 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-043-30 | 72789004330 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-043-30)Marketed from Dec 30, 2019 |
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)
- Medroxyprogesterone Acetate
- Generic name (nonproprietary)
- medroxyprogesterone acetate
- Active ingredients
- Medroxyprogesterone acetate — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- 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 72789-043_40312dd9-3554-cdfb-e063-6394a90a3638SPL ID 40312dd9-3554-cdfb-e063-6394a90a3638SPL set ID 6a541749-5d14-44aa-a409-5e51f5bbf929RxCUI 1000135UNII C2QI4IOI2GUPC 0372789043302
- 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
N472789004330followed by a unit qualifier and the quantityPackage 72789-0043-30. 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.
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 5 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0555-0873 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-0491 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 2.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-0490 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8824 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8825 |
| 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 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 | Preferred Pharmaceuticals Inc. | 68788-8112 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | American Health Packaging | 60687-105 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | Proficient Rx LP | 63187-382 |
| 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 | A-S Medication Solutions | 50090-0166 |
| 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 | REMEDYREPACK INC. | 70518-4666 |
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