Orgovyx
- Product NDC
- 72974-120
- 11-digit product format
- 729740120
- Labeler code
- 72974
- Product ID
- 72974-120_0d9200dd-878e-4e93-98af-e1149e84c21f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- relugolix
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sumitomo Pharma America, Inc.
- Application
- NDA214621
- Marketing category
- NDA
- Marketing start
- 2020-12-18
- Substance
- RELUGOLIX
- Active strength
- 120 mg/1
- Pharmacologic classes
- Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Orgovyx
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RELUGOLIX | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P76B05O5V6 |
| Rxcui | 2472783, 2472789 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72974-120-01 | Orgovyx | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 12 |
| 72974-120-95 | Orgovyx | 16 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 16 | | 12 |
| 72974-120-97 | Orgovyx | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72974-120 | ORGOVYX (RELUGOLIX) TABLET, FILM COATED [SUMITOMO PHARMA AMERICA, INC.] | 11 | Current NDC, Legacy NDC, 3 package rows | 20241031_077a92f6-9f1b-479a-87c7-c92b5db6aa9c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72974-120-01 | 72974012001 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-01) | 2020-12-18 | 0000-00-00 | No | No | Current |
| 72974-120-95 | 72974012095 | 16 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-95) | 2023-01-27 | | Yes | No | Current |
| 72974-120-97 | 72974012097 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-97) | 2021-10-21 | 0000-00-00 | Yes | No | Current |