DONEPEZIL HYDROCHLORIDE
- Product NDC
- 59746-329
- 11-digit product format
- 597460329
- Labeler code
- 59746
- Product ID
- 59746-329_8a92fbfc-6c69-4af8-84d3-ef4bfbae6b32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DONEPEZIL HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Jubilant Cadista Pharmaceuticals Inc.
- Application
- ANDA090768
- Marketing category
- ANDA
- Marketing start
- 2011-05-31
- Marketing end
- 0000-00-00
- Substance
- DONEPEZIL HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Donepezil Hydrochloride | ACTIVE INGREDIENT | 3O2T2PJ89D | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| Donepezil | ACTIVE MOIETY | 8SSC91326P | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| Hydroxypropyl Cellulose, Low Substituted | INACTIVE INGREDIENT | 2165RE0K14 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| Hypromellose 2910 (6 Mpa.s) | INACTIVE INGREDIENT | 0WZ8WG20P6 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| Lactose Monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| Polyethylene Glycol 8000 | INACTIVE INGREDIENT | Q662QK8M3B | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| Starch, Corn | INACTIVE INGREDIENT | O8232NY3SJ | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59746-329 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] | 7 | Legacy NDC | 20190904_0baef0fd-e6c0-4ee8-bb7e-1d2e89d6e0ec.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59746-329-01 | 59746032901 | 100 TABLET, FILM COATED in 1 BOTTLE (59746-329-01) | | 2011-05-31 | 0000-00-00 | No | No | Current |
| 59746-329-03 | 59746032903 | 10 BLISTER PACK in 1 CARTON (59746-329-03) > 10 TABLET, FILM COATED in 1 BLISTER PACK (59746-329-12) | 10 blister pack | 2011-05-31 | 0000-00-00 | No | No | Current |
| 59746-329-05 | 59746032905 | 500 TABLET, FILM COATED in 1 BOTTLE (59746-329-05) | | 2011-05-31 | 0000-00-00 | No | No | Current |
| 59746-329-10 | 59746032910 | 1000 TABLET, FILM COATED in 1 BOTTLE (59746-329-10) | | 2011-05-31 | 0000-00-00 | No | No | Current |
| 59746-329-30 | 59746032930 | 30 TABLET, FILM COATED in 1 BOTTLE (59746-329-30) | | 2011-05-31 | 0000-00-00 | No | No | Current |
| 59746-329-90 | 59746032990 | 90 TABLET, FILM COATED in 1 BOTTLE (59746-329-90) | | 2011-05-31 | 0000-00-00 | No | No | Current |