Benztropine Mesylate
- Product NDC
- 68475-512
- 11-digit product format
- 684750512
- Labeler code
- 68475
- Product ID
- 68475-512_29929540-0861-42fa-9b0b-6675023ee007
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benztropine Mesylate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Navinta LLC
- Application
- ANDA091525
- Marketing category
- ANDA
- Marketing start
- 2020-11-24
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Benztropine Mesylate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZTROPINE MESYLATE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WMJ8TL7510 |
| Rxcui | 885205 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68475-512-01 | Benztropine Mesylate | 2 mL in 1 VIAL | INJECTION | 2 | | 6 |
| 68475-512-02 | Benztropine Mesylate | 5 in 1 CARTON | INJECTION | 5 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68475-512 | BENZTROPINE MESYLATE INJECTION [NAVINTA LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241228_f92fbafa-314d-4449-831f-26108339e6b2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68475-512-01 | 68475051201 | 2 mL in 1 VIAL | 2 ml | | | | | Historical |
| 68475-512-02 | 68475051202 | 5 VIAL in 1 CARTON (68475-512-02) / 2 mL in 1 VIAL (68475-512-01) | 5 vial | 2020-11-24 | 0000-00-00 | No | No | Current |