Phenelzine Sulfate
- Product NDC
- 43386-360
- 11-digit product format
- 433860360
- Labeler code
- 43386
- Product ID
- 43386-360_1eb0b695-ce65-45c2-914a-87bc2105b139
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phenelzine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA200181
- Marketing category
- ANDA
- Marketing start
- 2010-12-14
- Substance
- PHENELZINE SULFATE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase 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
- Phenelzine Sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENELZINE SULFATE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2681D7P965 |
| Rxcui | 312347 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-360-21 | Phenelzine Sulfate | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PHENELZINE SULFATE | ACTIVE INGREDIENT | 2681D7P965 | PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| PHENELZINE | ACTIVE MOIETY | O408N561GF | PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PHENELZINE SULFATE TABLET [GAVIS PHARMACEUTICALS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-360 | PHENELZINE SULFATE TABLET [LUPIN PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20171016_40483372-448f-4284-976c-8462ef256661.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43386-360-21 | 43386036021 | 60 TABLET in 1 BOTTLE (43386-360-21) | 60 tablet | 2011-02-14 | 0000-00-00 | No | No | Current |