Prescription drug · ANDA
Medroxyprogesterone Acetate NDC 63629-2612
Medroxyprogesterone acetate 10 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2612-1 | 63629261201 | 10 TABLET in 1 BOTTLE (63629-2612-1)Marketed from Jun 13, 2011 | |
| 63629-2612-2 | 63629261202 | 30 TABLET in 1 BOTTLE (63629-2612-2)Marketed from Aug 17, 2007 | |
| 63629-2612-3 | 63629261203 | 5 TABLET in 1 BOTTLE (63629-2612-3)Marketed from Aug 12, 2011 | |
| 63629-2612-4 | 63629261204 | 60 TABLET in 1 BOTTLE (63629-2612-4)Marketed from Jun 14, 2016 | |
| 63629-2612-5 | 63629261205 | 90 TABLET in 1 BOTTLE (63629-2612-5)Marketed from Jul 28, 2021 | |
| 63629-2612-6 | 63629261206 | 20 TABLET in 1 BOTTLE (63629-2612-6)Marketed from Jul 8, 2024 | |
| 63629-2612-7 | 63629261207 | 100 TABLET in 1 BOTTLE (63629-2612-7)Marketed from Oct 9, 2017 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 63629-2612_73260b93-2e18-45ed-88f8-dbb0b33e91e1SPL ID 73260b93-2e18-45ed-88f8-dbb0b33e91e1SPL set ID bdb89690-ced2-48e1-bb1a-e5eccfeda8ebRxCUI 1000114UNII C2QI4IOI2G
- 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
N463629261201followed by a unit qualifier and the quantityPackage 63629-2612-01. 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, 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 2.5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-043 |
| 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 |
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