Atomoxetine
- Product NDC
- 55111-563
- 11-digit product format
- 551110563
- Labeler code
- 55111
- Product ID
- 55111-563_d266ad8b-af60-8e42-149b-e881323543a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atomoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA090609
- Marketing category
- ANDA
- Marketing start
- 2018-02-23
- Substance
- ATOMOXETINE HYDROCHLORIDE
- Active strength
- 80 mg/1
- Pharmacologic classes
- Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake 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
- Atomoxetine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATOMOXETINE HYDROCHLORIDE | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57WVB6I2W0 |
| Rxcui | 349591, 349592, 349593, 349594, 349595, 608139, 608143 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55111-563-05 | Atomoxetine | 500 in 1 BOTTLE | CAPSULE | 500 | | 8 |
| 55111-563-30 | Atomoxetine | 30 in 1 BOTTLE | CAPSULE | 30 | | 8 |
| 55111-563-78 | Atomoxetine | 100 in 1 CARTON | CAPSULE | 100 | | 8 |
| 55111-563-79 | Atomoxetine | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-563 | ATOMOXETINE CAPSULE [DR. REDDY'S LABORATORIES LIMITED] | 8 | Current NDC, Legacy NDC, 4 package rows | 20220304_973bdc9b-6421-7e00-e2b6-3cce036d363e.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 |
|---|
| 55111-563-05 | 55111056305 | 500 CAPSULE in 1 BOTTLE (55111-563-05) | 500 capsule | 2018-02-23 | 0000-00-00 | No | No | Current |
| 55111-563-30 | 55111056330 | 30 CAPSULE in 1 BOTTLE (55111-563-30) | 30 capsule | 2018-02-23 | 0000-00-00 | No | No | Current |
| 55111-563-78 | 55111056378 | 100 BLISTER PACK in 1 CARTON (55111-563-78) / 10 CAPSULE in 1 BLISTER PACK (55111-563-79) | 100 blister pack | 2018-02-23 | 0000-00-00 | No | No | Current |
| 55111-563-79 | 55111056379 | 10 in 1 BLISTER PACK | | | | | | Historical |