Prescription drug · ANDA
Progesterone NDC 70518-2560
Progesterone 100 mg/1 · Capsule · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-2560-0 | 70518256000 | 90 CAPSULE in 1 BOTTLE, PLASTIC (70518-2560-0)Marketed from Jan 30, 2020 |
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)
- Progesterone
- Generic name (nonproprietary)
- progesterone
- Active ingredients
- Progesterone — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211285
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone (Chemical structure)
- Identifiers
- Product ID 70518-2560_579818ae-8f52-9e5a-e063-6394a90ae6d1SPL ID 579818ae-8f52-9e5a-e063-6394a90ae6d1SPL set ID f7615864-be6e-47b4-bf35-145a361d7cc6RxCUI 260243UNII 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
N470518256000followed by a unit qualifier and the quantityPackage 70518-2560-00. 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 211285
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 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1406 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5928 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | NorthStar Rx LLC | 72603-975 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | NorthStar Rx LLC | 72603-974 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1443 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4015 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | direct rx | 72189-204 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3952 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3953 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | direct rx | 72189-217 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4068 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-542 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-072 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-073 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-152 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-153 |