TRIHEXYPHENIDYL HYDROCHLORIDE
- Product NDC
- 70518-2410
- 11-digit product format
- 705182410
- Labeler code
- 70518
- Product ID
- 70518-2410_4df040c5-8fee-a4fb-e063-6294a90a1043
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRIHEXYPHENIDYL HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA040254
- Marketing category
- ANDA
- Marketing start
- 2019-11-08
- Substance
- TRIHEXYPHENIDYL HYDROCHLORIDE
- Active strength
- 2 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TRIHEXYPHENIDYL HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRIHEXYPHENIDYL HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AO61G82577 |
| Rxcui | 905269 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 70518-2410-0 | 2023-03-09 | C162847 | 48780-1 | f386c649-d333-0266-e053-dadaa90a7c1a | Novitium Pharma LLC. TRIHEXYPHENIDYL HYDROCHLORIDE Tablets, USP 2 mg and 5 mg Rx Only |
| 70518-2410-0 | 2023-03-09 | C162847 | 48780-1 | f386c649-d333-0266-e053-dadaa90a7c1a | Novitium Pharma LLC. TRIHEXYPHENIDYL HYDROCHLORIDE Tablets, USP 2 mg and 5 mg Rx Only |
| 70518-2410-2 | 2023-03-09 | C162847 | 48780-1 | f386c649-d333-0266-e053-dadaa90a7c1a | Novitium Pharma LLC. TRIHEXYPHENIDYL HYDROCHLORIDE Tablets, USP 2 mg and 5 mg Rx Only |
| 70518-2410-2 | 2023-03-09 | C162847 | 48780-1 | f386c649-d333-0266-e053-dadaa90a7c1a | Novitium Pharma LLC. TRIHEXYPHENIDYL HYDROCHLORIDE Tablets, USP 2 mg and 5 mg Rx Only |
| 70518-2410-3 | 2023-03-09 | C162847 | 48780-1 | f386c649-d333-0266-e053-dadaa90a7c1a | Novitium Pharma LLC. TRIHEXYPHENIDYL HYDROCHLORIDE Tablets, USP 2 mg and 5 mg Rx Only |
| 70518-2410-3 | 2023-03-09 | C162847 | 48780-1 | f386c649-d333-0266-e053-dadaa90a7c1a | Novitium Pharma LLC. TRIHEXYPHENIDYL HYDROCHLORIDE Tablets, USP 2 mg and 5 mg Rx Only |
| 70518-2410-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-d333-0266-e053-dadaa90a7c1a | Novitium Pharma LLC. TRIHEXYPHENIDYL HYDROCHLORIDE Tablets, USP 2 mg and 5 mg Rx Only |
| 70518-2410-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-d333-0266-e053-dadaa90a7c1a | Novitium Pharma LLC. TRIHEXYPHENIDYL HYDROCHLORIDE Tablets, USP 2 mg and 5 mg Rx Only |
| 70518-2410-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-d333-0266-e053-dadaa90a7c1a | Novitium Pharma LLC. TRIHEXYPHENIDYL HYDROCHLORIDE Tablets, USP 2 mg and 5 mg Rx Only |
| 70518-2410-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-d333-0266-e053-dadaa90a7c1a | Novitium Pharma LLC. TRIHEXYPHENIDYL HYDROCHLORIDE Tablets, USP 2 mg and 5 mg Rx Only |
| 70518-2410-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-d333-0266-e053-dadaa90a7c1a | Novitium Pharma LLC. TRIHEXYPHENIDYL HYDROCHLORIDE Tablets, USP 2 mg and 5 mg Rx Only |
| 70518-2410-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-d333-0266-e053-dadaa90a7c1a | Novitium Pharma LLC. TRIHEXYPHENIDYL HYDROCHLORIDE Tablets, USP 2 mg and 5 mg Rx Only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-2410-0 | TRIHEXYPHENIDYL HYDROCHLORIDE | 100 in 1 BOX | TABLET | 100 | | 12 |
| 70518-2410-1 | TRIHEXYPHENIDYL HYDROCHLORIDE | 1 in 1 POUCH | TABLET | 1 | | 12 |
| 70518-2410-2 | TRIHEXYPHENIDYL HYDROCHLORIDE | 30 in 1 BLISTER PACK | TABLET | 30 | | 12 |
| 70518-2410-3 | TRIHEXYPHENIDYL HYDROCHLORIDE | 100 in 1 BOX | TABLET | 100 | | 12 |
| 70518-2410-4 | TRIHEXYPHENIDYL HYDROCHLORIDE | 1 in 1 POUCH | TABLET | 1 | | 12 |
| 70518-2410-5 | TRIHEXYPHENIDYL HYDROCHLORIDE | 30 in 1 BLISTER PACK | TABLET | 30 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2410 | TRIHEXYPHENIDYL HYDROCHLORIDE TABLET [REMEDYREPACK INC.] | 9 | Current NDC, Legacy NDC, 6 package rows | 20250228_b60ef86c-b8b6-4530-baaf-d4671ce961af.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 |
|---|
| 70518-2410-0 | 70518241000 | 100 POUCH in 1 BOX (70518-2410-0) > 1 TABLET in 1 POUCH (70518-2410-1) | 100 pouch | 2019-11-08 | 0000-00-00 | No | No | Current |
| 70518-2410-1 | 70518241001 | 1 in 1 POUCH | | | | | | Historical |
| 70518-2410-2 | 70518241002 | 30 TABLET in 1 BLISTER PACK (70518-2410-2) | 30 tablet | 2021-05-04 | 0000-00-00 | No | No | Current |
| 70518-2410-3 | 70518241003 | 100 POUCH in 1 BOX (70518-2410-3) > 1 TABLET in 1 POUCH (70518-2410-4) | 100 pouch | 2021-07-16 | 0000-00-00 | No | No | Current |
| 70518-2410-4 | 70518241004 | 1 in 1 POUCH | | | | | | Historical |
| 70518-2410-5 | 70518241005 | 30 TABLET in 1 BLISTER PACK (70518-2410-5) | 30 tablet | 2023-05-10 | | No | No | Current |