Prescription drug · ANDA
Progesterone NDC 76420-059
Progesterone 200 mg/1 · Capsule · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-059-10 | 76420005910 | 100 CAPSULE in 1 BOTTLE (76420-059-10)Marketed from Dec 16, 2019 | |
| 76420-059-30 | 76420005930 | 30 CAPSULE in 1 BOTTLE (76420-059-30)Marketed from Dec 16, 2019 | |
| 76420-059-90 | 76420005990 | 90 CAPSULE in 1 BOTTLE (76420-059-90)Marketed from Dec 16, 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)
- Progesterone
- Generic name (nonproprietary)
- progesterone
- Active ingredients
- Progesterone — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- 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 76420-059_ead2bd7f-b5e3-3c69-e053-2995a90adf37SPL ID ead2bd7f-b5e3-3c69-e053-2995a90adf37SPL set ID 19716042-8025-43a3-b26d-e0fd7d2587ebRxCUI 260243, 312641UNII 4G7DS2Q64Y
- 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
N476420005910followed by a unit qualifier and the quantityPackage 76420-0059-10. 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 . This label includes a boxed warning.
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 200 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-808 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4552 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-058 |