Strattera
- Product NDC
- 68151-4484
- 11-digit product format
- 681514484
- Labeler code
- 68151
- Product ID
- 68151-4484_e0dfed21-1067-40b2-b482-210d7c971dc8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atomoxetine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Carilion Materials Management
- Application
- NDA021411
- Marketing category
- NDA
- Marketing start
- 2003-01-10
- Marketing end
- 0000-00-00
- Substance
- ATOMOXETINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0d16f546-db6a-1939-50fc-d06382424c97 | Product name | 4 | 20210903 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68151-4484-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cb86-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use STRATTERA safely and effectively. See full prescribing information for STRATTERA. STRATTERA (atomoxetine) CAPSULES for Oral Use Initial U.S. Approval: 2002 ® |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68151-4484-3 | Strattera | 1 in 1 PACKAGE | CAPSULE | 1 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Atomoxetine hydrochloride | ACTIVE INGREDIENT | 57WVB6I2W0 | STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 | |
| Atomoxetine | ACTIVE MOIETY | ASW034S0B8 | STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68151-4484 | STRATTERA (ATOMOXETINE HYDROCHLORIDE) CAPSULE [CARILION MATERIALS MANAGEMENT] | 2 | Legacy NDC, 1 package rows | 20140822_6a7584b5-524d-4726-86a2-1b08e422f60e.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 349591 | atomoxetine HCl 10 MG Oral Capsule | PSN | 6a7584b5-524d-4726-86a2-1b08e422f60e | 2 |
| 352317 | Strattera 10 MG Oral Capsule | PSN | 6a7584b5-524d-4726-86a2-1b08e422f60e | 2 |
| 352317 | atomoxetine 10 MG Oral Capsule [Strattera] | SBD | 6a7584b5-524d-4726-86a2-1b08e422f60e | 2 |
| 349591 | atomoxetine 10 MG Oral Capsule | SCD | 6a7584b5-524d-4726-86a2-1b08e422f60e | 2 |
| 349591 | atomoxetine 10 MG (as atomoxetine hydrochloride) Oral Capsule | SY | 6a7584b5-524d-4726-86a2-1b08e422f60e | 2 |
| 352317 | Strattera 10 MG Oral Capsule | SY | 6a7584b5-524d-4726-86a2-1b08e422f60e | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68151-4484-3 | 68151448403 | 1 in 1 PACKAGE | Historical |