Prescription drug · ANDA
Progesterone NDC 65162-808
Progesterone 200 mg/1 · Capsule · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-808-10 | 65162080810 | 100 CAPSULE in 1 BOTTLE (65162-808-10)Marketed from Sep 11, 2017 | |
| 65162-808-50 | 65162080850 | 500 CAPSULE in 1 BOTTLE (65162-808-50)Marketed from Sep 11, 2017 |
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)
- Progesterone
- Generic name (nonproprietary)
- progesterone
- Active ingredients
- Progesterone — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207724
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone (Chemical structure)
- Identifiers
- Product ID 65162-808_6f7c3e58-3b68-4d6f-8502-74a41478d1c4SPL ID 6f7c3e58-3b68-4d6f-8502-74a41478d1c4SPL set ID 4de0715d-a3b9-42fa-b4e4-6371151fd75cRxCUI 260243, 312641UNII 4G7DS2Q64YUPC 0365162808100, 0365162807103
- Pharmacologic class
- Progesterone
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
N465162080810followed by a unit qualifier and the quantityPackage 65162-0808-10. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207724
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 |
|---|---|---|---|---|
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | AvKARE | 73190-064 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | AvKARE | 73190-065 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1432 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-807 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4552 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-058 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-059 |