BENZTROPINE MESYLATE
- Product NDC
- 70518-0577
- 11-digit product format
- 705180577
- Labeler code
- 70518
- Product ID
- 70518-0577_4d667ed6-144c-cb0e-e063-6294a90ad70d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BENZTROPINE MESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090168
- Marketing category
- ANDA
- Marketing start
- 2017-06-19
- Substance
- BENZTROPINE MESYLATE
- Active strength
- 1 mg/1
- 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/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WMJ8TL7510 |
| Rxcui | 885213 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-0577-0 | BENZTROPINE MESYLATE | 30 in 1 BLISTER PACK | TABLET | 30 | | 25 |
| 70518-0577-1 | BENZTROPINE MESYLATE | 28 in 1 BLISTER PACK | TABLET | 28 | | 25 |
| 70518-0577-2 | BENZTROPINE MESYLATE | 30 in 1 BLISTER PACK | TABLET | 30 | | 25 |
| 70518-0577-3 | BENZTROPINE MESYLATE | 100 in 1 BOX | TABLET | 100 | | 25 |
| 70518-0577-4 | BENZTROPINE MESYLATE | 1 in 1 POUCH | TABLET | 1 | | 25 |
| 70518-0577-5 | BENZTROPINE MESYLATE | 100 in 1 BOX | TABLET | 100 | | 25 |
| 70518-0577-6 | BENZTROPINE MESYLATE | 1 in 1 POUCH | TABLET | 1 | | 25 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-0577 | BENZTROPINE MESYLATE TABLET [REMEDYREPACK INC.] | 15 | Current NDC, Legacy NDC, 7 package rows | 20250429_01688e6f-7b22-41bf-9a85-1c88d90f99b6.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 |
|---|
| 70518-0577-0 | 70518057700 | 30 TABLET in 1 BLISTER PACK (70518-0577-0) | 30 tablet | 2017-06-19 | 0000-00-00 | No | No | Current |
| 70518-0577-1 | 70518057701 | 28 TABLET in 1 BLISTER PACK (70518-0577-1) | 28 tablet | 2020-06-03 | 0000-00-00 | No | No | Current |
| 70518-0577-2 | 70518057702 | 30 TABLET in 1 BLISTER PACK (70518-0577-2) | 30 tablet | 2020-06-09 | 0000-00-00 | No | No | Current |
| 70518-0577-3 | 70518057703 | 100 POUCH in 1 BOX (70518-0577-3) > 1 TABLET in 1 POUCH (70518-0577-4) | 100 pouch | 2022-02-03 | 0000-00-00 | No | No | Current |
| 70518-0577-4 | 70518057704 | 1 in 1 POUCH | | | | | | Historical |
| 70518-0577-5 | 70518057705 | 100 POUCH in 1 BOX (70518-0577-5) / 1 TABLET in 1 POUCH (70518-0577-6) | 100 pouch | 2026-01-23 | | No | No | Historical |
| 70518-0577-6 | 70518057706 | 1 in 1 POUCH | | | | | | Historical |