Fluoxetine Hydrochloride
- Product NDC
- 21695-321
- 11-digit product format
- 216950321
- Labeler code
- 21695
- Product ID
- 21695-321_10a49211-025b-4d63-b60c-fadfd9b731c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluoxetine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA075755
- Marketing category
- ANDA
- Marketing start
- 2010-01-13
- Marketing end
- 0000-00-00
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21695-321-00 | Fluoxetine Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 1 |
| 21695-321-30 | Fluoxetine Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
| 21695-321-60 | Fluoxetine Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
| 21695-321-90 | Fluoxetine Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUOXETINE HYDROCHLORIDE | ACTIVE INGREDIENT | I9W7N6B1KJ | FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| FLUOXETINE | ACTIVE MOIETY | 01K63SUP8D | FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-321 | FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 4 package rows | 20110103_10a49211-025b-4d63-b60c-fadfd9b731c0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-321-00 | 21695032100 | 100 in 1 BOTTLE, PLASTIC | Historical |
| 21695-321-30 | 21695032130 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 21695-321-60 | 21695032160 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 21695-321-90 | 21695032190 | 90 in 1 BOTTLE, PLASTIC | Historical |