Rozerem
- Product NDC
- 21695-183
- 11-digit product format
- 216950183
- Labeler code
- 21695
- Product ID
- 21695-183_3740dcc6-9ee8-4187-9112-632050043240
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ramelteon
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA021782
- Marketing category
- NDA
- Marketing start
- 2005-07-22
- Marketing end
- 0000-00-00
- Substance
- RAMELTEON
- Active strength
- 8 mg/1
- Pharmacologic classes
- Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [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 |
|---|
| 21695-183-30 | Rozerem | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ramelteon | ACTIVE INGREDIENT | 901AS54I69 | ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| ramelteon | ACTIVE MOIETY | 901AS54I69 | ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| copovidone | INACTIVE INGREDIENT | D9C330MD8B | ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| ferrosoferric oxide | INACTIVE INGREDIENT | XM0M87F357 | ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| hydroxypropyl cellulose | INACTIVE INGREDIENT | RFW2ET671P | ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| polyethylene glycol 8000 | INACTIVE INGREDIENT | Q662QK8M3B | ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| shellac | INACTIVE INGREDIENT | 46N107B71O | ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ROZEREM (RAMELTEON) 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 |
|---|
| 21695-183 | ROZEREM (RAMELTEON) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 1 package rows | 20101201_3740dcc6-9ee8-4187-9112-632050043240.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-183-30 | 21695018330 | 30 in 1 BOTTLE | Historical |