Galantamine Hydrobromide
- Product NDC
- 51990-112
- 11-digit product format
- 519900112
- Labeler code
- 51990
- Product ID
- 51990-112_a602c1a5-0c9c-4489-bc71-5fd6e0b06cae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- galantamine hydrobromide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Yabao Pharmaceutical Co., Ltd. Beijing
- Application
- NDA021169
- Marketing category
- NDA
- Marketing start
- 2001-03-01
- Marketing end
- 0000-00-00
- Substance
- GALANTAMINE HYDROBROMIDE
- Active strength
- 8 mg/1
- Pharmacologic classes
- Cholinesterase Inhibitor [EPC],Cholinesterase 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 |
|---|
| 51990-112-02 | Galantamine Hydrobromide | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 51990-112-03 | Galantamine Hydrobromide | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 1 |
| 51990-112-04 | Galantamine Hydrobromide | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| galantamine hydrobromide | ACTIVE INGREDIENT | MJ4PTD2VVW | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| galantamine | ACTIVE MOIETY | 0D3Q044KCA | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE E) | INACTIVE INGREDIENT | 66O7AQV0RT | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51990-112 | GALANTAMINE HYDROBROMIDE TABLET, FILM COATED [YABAO PHARMACEUTICAL CO., LTD. BEIJING] | 1 | Legacy NDC, 3 package rows | 20150602_7dc963dd-84d6-45f3-857f-46a44fe9edc8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 51990-112-02 | 51990011202 | 100 in 1 BOTTLE | Historical |
| 51990-112-03 | 51990011203 | 1000 in 1 BOTTLE | Historical |
| 51990-112-04 | 51990011204 | 60 in 1 BOTTLE | Historical |