atomoxetine
- Product NDC
- 68382-219
- 11-digit product format
- 683820219
- Labeler code
- 68382
- Product ID
- 68382-219_ffa27721-74b3-4ad8-b4c3-8aa29c67861c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- atomoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA079017
- Marketing category
- ANDA
- Marketing start
- 2017-12-06
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|---|
| 68382-219-02 | atomoxetine | 2000 in 1 BOTTLE | CAPSULE | 2000 | 6 | |
| 68382-219-06 | atomoxetine | 30 in 1 BOTTLE | CAPSULE | 30 | 6 | |
| 68382-219-10 | atomoxetine | 1000 in 1 BOTTLE | CAPSULE | 1000 | 6 | |
| 68382-219-14 | atomoxetine | 60 in 1 BOTTLE | CAPSULE | 60 | 6 | |
| 68382-219-16 | atomoxetine | 90 in 1 BOTTLE | CAPSULE | 90 | 6 | |
| 68382-219-30 | atomoxetine | 10 in 1 BLISTER PACK | CAPSULE | 10 | 6 | |
| 68382-219-77 | atomoxetine | 10 in 1 CARTON | CAPSULE | 10 | 6 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 349591 | atomoxetine HCl 10 MG Oral Capsule | PSN | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 608139 | atomoxetine HCl 100 MG Oral Capsule | PSN | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 349592 | atomoxetine HCl 18 MG Oral Capsule | PSN | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 349593 | atomoxetine HCl 25 MG Oral Capsule | PSN | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 349594 | atomoxetine HCl 40 MG Oral Capsule | PSN | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 349595 | atomoxetine HCl 60 MG Oral Capsule | PSN | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 608143 | atomoxetine HCl 80 MG Oral Capsule | PSN | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 349591 | atomoxetine 10 MG Oral Capsule | SCD | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 608139 | atomoxetine 100 MG Oral Capsule | SCD | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 349592 | atomoxetine 18 MG Oral Capsule | SCD | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 349593 | atomoxetine 25 MG Oral Capsule | SCD | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 349594 | atomoxetine 40 MG Oral Capsule | SCD | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 349595 | atomoxetine 60 MG Oral Capsule | SCD | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 608143 | atomoxetine 80 MG Oral Capsule | SCD | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 349591 | atomoxetine 10 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 608139 | atomoxetine 100 MG (as atomoxetine HCl) Oral Capsule | SY | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 349592 | atomoxetine 18 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 349593 | atomoxetine 25 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 349594 | atomoxetine 40 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 349595 | atomoxetine 60 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
| 608143 | atomoxetine 80 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 5f89c7c9-4c25-4ba2-ad90-5aeadb48f214 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68382-219-02 | 68382021902 | 2000 CAPSULE in 1 BOTTLE (68382-219-02) | 2000 capsule | 2017-12-06 | 0000-00-00 | No | No | Current |
| 68382-219-06 | 68382021906 | 30 CAPSULE in 1 BOTTLE (68382-219-06) | 30 capsule | 2017-12-06 | 0000-00-00 | No | No | Current |
| 68382-219-10 | 68382021910 | 1000 CAPSULE in 1 BOTTLE (68382-219-10) | 1000 capsule | 2017-12-06 | 0000-00-00 | No | No | Current |
| 68382-219-14 | 68382021914 | 60 CAPSULE in 1 BOTTLE (68382-219-14) | 60 capsule | 2017-12-06 | 0000-00-00 | No | No | Current |
| 68382-219-16 | 68382021916 | 90 CAPSULE in 1 BOTTLE (68382-219-16) | 90 capsule | 2017-12-06 | 0000-00-00 | No | No | Current |
| 68382-219-30 | 68382021930 | 10 in 1 BLISTER PACK | Historical | |||||
| 68382-219-77 | 68382021977 | 10 BLISTER PACK in 1 CARTON (68382-219-77) > 10 CAPSULE in 1 BLISTER PACK (68382-219-30) | 10 blister pack | 2017-12-06 | 0000-00-00 | No | No | Current |