Letrozole
- Product NDC
- 55111-646
- 11-digit product format
- 551110646
- Labeler code
- 55111
- Product ID
- 55111-646_ec1b249b-2d77-55d9-0520-23884a961cf0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Letrozole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA091191
- Marketing category
- ANDA
- Marketing start
- 2011-06-03
- Substance
- LETROZOLE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Aromatase Inhibitor [EPC], Aromatase 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
- Letrozole
- Listing expiration
- 2026-12-31
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 |
|---|
| 55111-646-30 | Letrozole | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 55111-646-78 | Letrozole | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 6 |
| 55111-646-79 | Letrozole | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Letrozole | ACTIVE INGREDIENT | 7LKK855W8I | LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 4 | |
| letrozole | ACTIVE MOIETY | 7LKK855W8I | LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 4 | |
| colloidal silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 4 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 4 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 4 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 4 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 4 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 4 | |
| polyethylene glycol | INACTIVE INGREDIENT | 3WJQ0SDW1A | LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 4 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 4 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 4 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-646 | LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] | 6 | Current NDC, Legacy NDC, 3 package rows | 20181207_6cfd29d7-f519-7b8c-4814-07b39f367f0d.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 |
|---|
| 55111-646-30 | 55111064630 | 30 TABLET, FILM COATED in 1 BOTTLE (55111-646-30) | | 2011-06-03 | 0000-00-00 | No | No | Current |
| 55111-646-78 | 55111064678 | 10 BLISTER PACK in 1 CARTON (55111-646-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-646-79) | 10 blister pack | 2011-06-03 | 0000-00-00 | No | No | Current |
| 55111-646-79 | 55111064679 | 10 in 1 BLISTER PACK | | | | | | Historical |