Trexall
- Product NDC
- 51285-369
- 11-digit product format
- 512850369
- Labeler code
- 51285
- Product ID
- 51285-369_6743bd6d-9c6b-4f43-b444-8faa4b5d5221
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methotrexate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Women's Health, Inc.
- Application
- ANDA040385
- Marketing category
- ANDA
- Marketing start
- 2001-05-03
- Substance
- METHOTREXATE SODIUM
- Active strength
- 15 mg/1
- Pharmacologic classes
- Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism 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
- Trexall
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHOTREXATE SODIUM | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3IG1E710ZN |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51285-369-01 | Trexall | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METHOTREXATE SODIUM | ACTIVE INGREDIENT | 3IG1E710ZN | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| METHOTREXATE | ACTIVE MOIETY | YL5FZ2Y5U1 | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| INDIGOTINDISULFONATE SODIUM | INACTIVE INGREDIENT | D3741U8K7L | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| SODIUM CARBONATE MONOHYDRATE | INACTIVE INGREDIENT | 2A1Q1Q3557 | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51285-369 | TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] | 12 | Current NDC, Legacy NDC, 1 package rows | 20221001_e942f8db-510f-44d6-acb5-b822196f5e8c.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 |
|---|
| 51285-369-01 | 51285036901 | 30 TABLET, FILM COATED in 1 BOTTLE (51285-369-01) | 2001-05-03 | 0000-00-00 | No | No | Current |