Benztropine Mesylate
- Product NDC
- 53808-0825
- 11-digit product format
- 538080825
- Labeler code
- 53808
- Product ID
- 53808-0825_6e264c7b-8a87-4f75-8644-ba41b9f4398b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benztropine mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA040715
- Marketing category
- ANDA
- Marketing start
- 2013-01-01
- Marketing end
- 0000-00-00
- Substance
- BENZTROPINE MESYLATE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2961cf47-535c-c402-c24d-0a9130269674 | Product name | 3 | 20251121 |
| 3f930a8b-cc65-fba9-e4ca-58b6abcea16b | Product name | 2 | 20220509 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53808-0825-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4f42-f424-e053-dadaa90a57ce | BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-0825-1 | Benztropine Mesylate | 30 in 1 BLISTER PACK | TABLET | 30 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BENZTROPINE MESYLATE | ACTIVE INGREDIENT | WMJ8TL7510 | BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| BENZTROPINE | ACTIVE MOIETY | 1NHL2J4X8K | BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-0825 | BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | Legacy NDC, 1 package rows | 20140402_d7698133-5cbc-4014-87a6-f2af23cbdff0.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 885209 | benztropine mesylate 2 MG Oral Tablet | PSN | d7698133-5cbc-4014-87a6-f2af23cbdff0 | 2 |
| 885209 | benztropine mesylate 2 MG Oral Tablet | SCD | d7698133-5cbc-4014-87a6-f2af23cbdff0 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-0825-1 | 53808082501 | 30 in 1 BLISTER PACK | Historical |