Prescription drug · ANDA
Progesterone NDC 68788-4015
Progesterone 200 mg/1 · Capsule · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-4015-3 | 6878840150368788401503 | 30 CAPSULE in 1 BOTTLE (68788-4015-3)Marketed from Sep 5, 2025 |
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 — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- 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 68788-4015_c768aead-153b-42f3-bb4d-b06e30ebad80SPL ID c768aead-153b-42f3-bb4d-b06e30ebad80SPL set ID c768aead-153b-42f3-bb4d-b06e30ebad80RxCUI 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
N468788401503followed by a unit qualifier and the quantityPackage 68788-4015-03. 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.
About NDC 68788-4015
- What is NDC 68788-4015?
- 68788-4015 is the product NDC for Progesterone, Progesterone 200 mg/1 capsule, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Progesterone.
- What is the active ingredient?
- Progesterone.
- Who is the labeler?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Progesterone?
- 73 other product NDCs are listed under this name. See all Progesterone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Progesterone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | NorthStar Rx LLC | 72603-974 | 72603-0974-01 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | NorthStar Rx LLC | 72603-975 | 72603-0975-01 |
| Progesterone | Progesterone 100 mg/1 | InsertVaginal | Sun Pharmaceutical Industries, Inc. | 70095-136 | 70095-0136-03 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4068 | 68788-4068-03 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4552 | 70518-4552-00 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | Direct_Rx | 72189-654 | 72189-0654-90 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | AvKARE | 73190-064 | 73190-0064-01 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | AvKARE | 73190-065 | 73190-0065-01 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | Hikma Pharmaceuticals USA Inc | 0054-0829 | 00054-0829-25 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | Hikma Pharmaceuticals USA Inc | 0054-0830 | 00054-0830-25 |
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 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5928 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-542 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-152 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-153 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3952 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3953 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4068 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2560 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1406 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1443 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | direct rx | 72189-204 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | direct rx | 72189-217 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | NorthStar Rx LLC | 72603-974 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | NorthStar Rx LLC | 72603-975 |
| Progesterone | Progesterone 100 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-072 |
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-073 |