Mirtazapine
- Product NDC
- 53808-0482
- 11-digit product format
- 538080482
- Labeler code
- 53808
- Product ID
- 53808-0482_3d0fdbe3-37f0-4f8c-a132-76c2fd155c55
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA077666
- Marketing category
- ANDA
- Marketing start
- 2009-07-01
- Marketing end
- 0000-00-00
- Substance
- MIRTAZAPINE
- Active strength
- 15 mg/1
- 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 |
|---|
| 53808-0482-1 | Mirtazapine | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MIRTAZAPINE | ACTIVE INGREDIENT | A051Q2099Q | MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| MIRTAZAPINE | ACTIVE MOIETY | A051Q2099Q | MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| HYPROMELLOSE 2910 (6 CPS) | INACTIVE INGREDIENT | 0WZ8WG20P6 | MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53808-0482 | MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | Legacy NDC, 1 package rows | 20100813_34c0b734-98ca-4aec-965f-e55edd3317f3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53808-0482-1 | 53808048201 | 30 in 1 BLISTER PACK | Historical |