Atomoxetine
- Product NDC
- 55111-522
- 11-digit product format
- 551110522
- Labeler code
- 55111
- Product ID
- 55111-522_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
- 60 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 |
|---|---|
| ATOMOXETINE HYDROCHLORIDE | 60 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 57WVB6I2W0 |
| Rxcui | 349591, 349592, 349593, 349594, 349595, 608139, 608143 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0d16f546-db6a-1939-50fc-d06382424c97 | Product name | 4 | 20210903 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55111-522-05 | Atomoxetine | 500 in 1 BOTTLE | CAPSULE | 500 | 8 | |
| 55111-522-30 | Atomoxetine | 30 in 1 BOTTLE | CAPSULE | 30 | 8 | |
| 55111-522-78 | Atomoxetine | 100 in 1 CARTON | CAPSULE | 100 | 8 | |
| 55111-522-79 | Atomoxetine | 10 in 1 BLISTER PACK | CAPSULE | 10 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55111-522-30 | EA - Each | 55111-522 | 83ca8ff3-0e75-4e11-9429-63629f783f71 | 1 | 2018-12-13 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 349595 | atomoxetine HCl 60 MG Oral Capsule | PSN | 92de0ca1-6a02-4925-aefc-b32573d349a7 | 101 |
| 349595 | atomoxetine 60 MG Oral Capsule | SCD | 92de0ca1-6a02-4925-aefc-b32573d349a7 | 101 |
| 349595 | atomoxetine 60 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 92de0ca1-6a02-4925-aefc-b32573d349a7 | 101 |
| 349591 | atomoxetine HCl 10 MG Oral Capsule | PSN | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 608139 | atomoxetine HCl 100 MG Oral Capsule | PSN | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 349592 | atomoxetine HCl 18 MG Oral Capsule | PSN | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 349593 | atomoxetine HCl 25 MG Oral Capsule | PSN | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 349594 | atomoxetine HCl 40 MG Oral Capsule | PSN | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 349595 | atomoxetine HCl 60 MG Oral Capsule | PSN | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 608143 | atomoxetine HCl 80 MG Oral Capsule | PSN | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 349591 | atomoxetine 10 MG Oral Capsule | SCD | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 608139 | atomoxetine 100 MG Oral Capsule | SCD | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 349592 | atomoxetine 18 MG Oral Capsule | SCD | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 349593 | atomoxetine 25 MG Oral Capsule | SCD | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 349594 | atomoxetine 40 MG Oral Capsule | SCD | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 349595 | atomoxetine 60 MG Oral Capsule | SCD | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 608143 | atomoxetine 80 MG Oral Capsule | SCD | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 349591 | atomoxetine 10 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 608139 | atomoxetine 100 MG (as atomoxetine HCl) Oral Capsule | SY | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 349592 | atomoxetine 18 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 349593 | atomoxetine 25 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 349594 | atomoxetine 40 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 349595 | atomoxetine 60 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
| 608143 | atomoxetine 80 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 973bdc9b-6421-7e00-e2b6-3cce036d363e | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55111-522-05 | 55111052205 | 500 CAPSULE in 1 BOTTLE (55111-522-05) | 500 capsule | 2018-02-23 | 0000-00-00 | No | No | Current |
| 55111-522-30 | 55111052230 | 30 CAPSULE in 1 BOTTLE (55111-522-30) | 30 capsule | 2018-02-23 | 0000-00-00 | No | No | Current |
| 55111-522-78 | 55111052278 | 100 BLISTER PACK in 1 CARTON (55111-522-78) / 10 CAPSULE in 1 BLISTER PACK (55111-522-79) | 100 blister pack | 2018-02-23 | 0000-00-00 | No | No | Current |
| 55111-522-79 | 55111052279 | 10 in 1 BLISTER PACK | Historical |