Benztropine Mesylate
- Product NDC
- 17478-012
- 11-digit product format
- 174780012
- Labeler code
- 17478
- Product ID
- 17478-012_948e5595-bfad-4a9c-bd84-e112dcfb800f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benztropine Mesylate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Akorn
- Application
- NDA012015
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2012-08-08
- Marketing end
- 0000-00-00
- Substance
- BENZTROPINE MESYLATE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17478-012-02 | ML - Milliliter | 17478-012 | 007b029d-705b-4efa-9d27-17c7071380a5 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Benztropine Mesylate | ACTIVE INGREDIENT | WMJ8TL7510 | BENZTROPINE MESYLATE INJECTION [TYA PHARMACEUTICALS] | 2 | |
| Benztropine | ACTIVE MOIETY | 1NHL2J4X8K | BENZTROPINE MESYLATE INJECTION [TYA PHARMACEUTICALS] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | BENZTROPINE MESYLATE INJECTION [TYA PHARMACEUTICALS] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BENZTROPINE MESYLATE INJECTION [TYA PHARMACEUTICALS] | 2 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 885205 | benztropine mesylate 2 MG in 2 ML Injection | PSN | d61eae0d-a29d-45ef-bd41-07123e0c21f9 | 2 |
| 885205 | 2 ML benztropine mesylate 1 MG/ML Injection | SCD | d61eae0d-a29d-45ef-bd41-07123e0c21f9 | 2 |
| 885205 | benztropine mesylate 2 MG per 2 ML Injection | SY | d61eae0d-a29d-45ef-bd41-07123e0c21f9 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 17478-012-02 | 17478001202 | 5 AMPULE in 1 CARTON (17478-012-02) > 2 mL in 1 AMPULE | 5 ampule | 2012-08-08 | 0000-00-00 | No | No | Current |