Donepezil Hydrochloride
- Product NDC
- 50228-139
- 11-digit product format
- 502280139
- Labeler code
- 50228
- Product ID
- 50228-139_652d4a32-9c92-43df-be8a-a91cfaf61c3a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Donepezil Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals, Inc.
- Application
- ANDA203907
- Marketing category
- ANDA
- Marketing start
- 2014-10-29
- Substance
- DONEPEZIL HYDROCHLORIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Donepezil Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DONEPEZIL HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3O2T2PJ89D |
| Rxcui | 997223, 997229 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-139-10 | Donepezil Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 6 |
| 50228-139-30 | Donepezil Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
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 [SCIEGEN PHARMACEUTICALS, INC.] | 4 | |
| DONEPEZIL | ACTIVE MOIETY | 8SSC91326P | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 4 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 4 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 4 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 4 | |
| DONEPEZIL HYDROCHLORIDE | ACTIVE INGREDIENT | 3O2T2PJ89D | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] | 1 | |
| DONEPEZIL | ACTIVE MOIETY | 8SSC91326P | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] | 1 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] | 1 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-139 | DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20190330_6e9aacf9-abb6-4dec-9a8d-4eabf934d512.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50228-139-10 | 50228013910 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-139-10) | 2014-10-29 | 0000-00-00 | No | No | Current |
| 50228-139-30 | 50228013930 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-139-30) | 2014-10-29 | 0000-00-00 | No | No | Current |