Esterified Estrogens and Methyltestosterone
- Product NDC
- 53746-078
- 11-digit product format
- 537460078
- Labeler code
- 53746
- Product ID
- 53746-078_c2c9cf77-504d-4d7c-8899-c3cb6f76c545
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esterified Estrogens and Methyltestosterone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2010-09-22
- Substance
- ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE
- Active strength
- 1.25; 2.5 mg/1; mg/1
- Pharmacologic classes
- Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Esterified Estrogens and Methyltestosterone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTROGENS, ESTERIFIED | 1.25 mg/1 |
| METHYLTESTOSTERONE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3ASP8Q3768, V9EFU16ZIF |
| Rxcui | 197670, 238006 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53746-078-01 | Esterified Estrogens and Methyltestosterone | 100 in 1 BOTTLE | TABLET | 100 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESTROGENS, CONJUGATED | ACTIVE INGREDIENT | IU5QR144QX | ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] | 3 | |
| METHYLTESTOSTERONE | ACTIVE INGREDIENT | V9EFU16ZIF | ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] | 3 | |
| ESTROGENS, CONJUGATED | ACTIVE MOIETY | IU5QR144QX | ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] | 3 | |
| METHYLTESTOSTERONE | ACTIVE MOIETY | V9EFU16ZIF | ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] | 3 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] | 3 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-078 | ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 10 | Current NDC, Legacy NDC, 1 package rows | 20240101_316650b7-5770-4f1a-867d-68a72c60c8f2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53746-078-01 | 53746007801 | 100 TABLET in 1 BOTTLE (53746-078-01) | 100 tablet | 2010-09-22 | 0000-00-00 | No | No | Current |