Atomoxetine Hydrochloride
- Product NDC
- 70518-4313
- 11-digit product format
- 705184313
- Labeler code
- 70518
- Product ID
- 70518-4313_402dde79-775f-0a84-e063-6294a90a60c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- atomoxetine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078983
- Marketing category
- ANDA
- Marketing start
- 2025-03-19
- Substance
- ATOMOXETINE HYDROCHLORIDE
- Active strength
- 10 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 Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATOMOXETINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57WVB6I2W0 |
| Rxcui | 349591 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4313-0 | Atomoxetine Hydrochloride | 30 in 1 BOX | CAPSULE | 30 | | 3 |
| 70518-4313-1 | Atomoxetine Hydrochloride | 1 in 1 POUCH | CAPSULE | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4313 | ATOMOXETINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] | 1 | Current NDC, 2 package rows | 20250322_6d7ea8f7-981c-4acc-aeaf-7516325bfc0c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4313-0 | 70518431300 | 30 POUCH in 1 BOX (70518-4313-0) / 1 CAPSULE in 1 POUCH (70518-4313-1) | 30 pouch | 2025-03-19 | No | No | Historical |
| 70518-4313-1 | 70518431301 | 1 in 1 POUCH | | | | | Historical |