Benztropine Mesylate
- Product NDC
- 64125-137
- 11-digit product format
- 641250137
- Labeler code
- 64125
- Product ID
- 64125-137_819347a9-acae-47b6-bf37-72054d2a2269
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benztropine mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Excellium Pharmaceutical, Inc,
- Application
- ANDA090168
- Marketing category
- ANDA
- Marketing start
- 2012-12-01
- Marketing end
- 0000-00-00
- Substance
- BENZTROPINE MESYLATE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [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 |
|---|
| 64125-137-01 | Benztropine Mesylate | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 3 |
| 64125-137-10 | Benztropine Mesylate | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BENZTROPINE MESYLATE | ACTIVE INGREDIENT | WMJ8TL7510 | BENZTROPINE MESYLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC,] | 3 | |
| BENZTROPINE | ACTIVE MOIETY | 1NHL2J4X8K | BENZTROPINE MESYLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC,] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | BENZTROPINE MESYLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC,] | 3 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | BENZTROPINE MESYLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC,] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BENZTROPINE MESYLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC,] | 3 | |
| HYDROGENATED COTTONSEED OIL | INACTIVE INGREDIENT | Z82Y2C65EA | BENZTROPINE MESYLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC,] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | BENZTROPINE MESYLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC,] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | BENZTROPINE MESYLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC,] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | BENZTROPINE MESYLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC,] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64125-137 | BENZTROPINE MESYLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC,] | 3 | Legacy NDC, 2 package rows | 20141208_37eef247-c418-4cbe-aff2-d74d032ede1c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 64125-137-01 | 64125013701 | 100 in 1 BOTTLE, PLASTIC | Historical |
| 64125-137-10 | 64125013710 | 1000 in 1 BOTTLE, PLASTIC | Historical |