Savella
- Product NDC
- 21695-650
- 11-digit product format
- 216950650
- Labeler code
- 21695
- Product ID
- 21695-650_08214b30-3dab-4621-a6c0-6bb68529dee3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- milnacipran hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA022256
- Marketing category
- NDA
- Marketing start
- 2009-04-17
- Marketing end
- 0000-00-00
- Substance
- MILNACIPRAN HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine 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 |
|---|
| 21695-650-60 | Savella | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| milnacipran hydrochloride | ACTIVE INGREDIENT | RNZ43O5WW5 | SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| milnacipran | ACTIVE MOIETY | G56VK1HF36 | SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| carboxymethylcellulose calcium | INACTIVE INGREDIENT | UTY7PDF93L | SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| dibasic calcium phosphate dihydrate | INACTIVE INGREDIENT | O7TSZ97GEP | SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| fd&c blue no. 1 | INACTIVE INGREDIENT | H3R47K3TBD | SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| fd&c blue no. 2 | INACTIVE INGREDIENT | L06K8R7DQK | SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| fd&c yellow no. 5 | INACTIVE INGREDIENT | I753WB2F1M | SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| polyethylene glycol | INACTIVE INGREDIENT | 3WJQ0SDW1A | SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | SAVELLA (MILNACIPRAN 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 |
|---|
| 21695-650 | SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 1 package rows | 20101210_08214b30-3dab-4621-a6c0-6bb68529dee3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-650-60 | 21695065060 | 60 in 1 BOTTLE | Historical |