Letrozole
- Product NDC
- 16729-034
- 11-digit product format
- 167290034
- Labeler code
- 16729
- Product ID
- 16729-034_4a681bf4-9779-a1b2-e063-6294a90a83db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- letrozole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Accord Healthcare, Inc.
- Application
- ANDA090934
- Marketing category
- ANDA
- Marketing start
- 2011-06-02
- Substance
- LETROZOLE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Letrozole
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LETROZOLE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7LKK855W8I |
| Rxcui | 200064 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-034-01 | Letrozole | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 13 |
| 16729-034-10 | Letrozole | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 13 |
| 16729-034-15 | Letrozole | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 13 |
| 16729-034-16 | Letrozole | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 13 |
| 16729-034-17 | Letrozole | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 13 |
| 16729-034-43 | Letrozole | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 13 |
| 16729-034-43 | Letrozole | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LETROZOLE | ACTIVE INGREDIENT | 7LKK855W8I | LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 4 | |
| LETROZOLE | ACTIVE MOIETY | 7LKK855W8I | LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 4 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 4 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-034 | LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 12 | Current NDC, Legacy NDC, 7 package rows | 20250524_c391fe11-fd47-4a35-af6d-c823ab7b8838.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 |
|---|
| 16729-034-01 | 16729003401 | 100 in 1 BOTTLE | | | | | Historical |
| 16729-034-10 | 16729003410 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-034-10) | 2011-06-02 | 0000-00-00 | No | No | Current |
| 16729-034-15 | 16729003415 | 90 TABLET, FILM COATED in 1 BOTTLE (16729-034-15) | 2014-12-31 | 0000-00-00 | No | No | Current |
| 16729-034-16 | 16729003416 | 500 in 1 BOTTLE | | | | | Historical |
| 16729-034-17 | 16729003417 | 1000 in 1 BOTTLE | | | | | Historical |
| 16729-034-43 | 16729003443 | 100 in 1 CARTON | | | | | Historical |