tizanidine hydrochloride
- Product NDC
- 0185-0034
- 11-digit product format
- 001850034
- Labeler code
- 0185
- Product ID
- 0185-0034_2773d3c8-40a1-4a53-b67a-097c910f3ae0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tizanidine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Eon Labs, Inc.
- Application
- ANDA076280
- Marketing category
- ANDA
- Marketing start
- 2002-11-26
- Marketing end
- 2022-09-30
- Substance
- TIZANIDINE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a0ff02d8-b711-423c-b7d1-ada00d81c743 | Product name | 1 | 20250805 |
| 9fd28b3a-d1bb-a2ce-ffa3-c3dd28536a01 | Product name | 8 | 20250313 |
| b404127e-1c01-47bb-874e-db1e0b6bd9af | Product name | 4 | 20250313 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0185-0034-10 | EA - Each | 0185-0034 | 05a96f71-1431-40c9-9043-29573c6bee36 | 1 | 2012-07-24 |
| 0185-0034-51 | EA - Each | 0185-0034 | f0aca024-96b4-45ad-a507-cf176eced1e2 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TIZANIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | B53E3NMY5C | TIZANIDINE HYDROCHLORIDE TABLET [STAT RX USA LLC] | 3 | |
| TIZANIDINE | ACTIVE MOIETY | 6AI06C00GW | TIZANIDINE HYDROCHLORIDE TABLET [STAT RX USA LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TIZANIDINE HYDROCHLORIDE TABLET [STAT RX USA LLC] | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TIZANIDINE HYDROCHLORIDE TABLET [STAT RX USA LLC] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TIZANIDINE HYDROCHLORIDE TABLET [STAT RX USA LLC] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | TIZANIDINE HYDROCHLORIDE TABLET [STAT RX USA LLC] | 3 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313412 | tiZANidine HCl 2 MG Oral Tablet | PSN | 43d51c1d-5f5b-4b9e-95d0-d12ceff8d84e | 3 |
| 313413 | tiZANidine HCl 4 MG Oral Tablet | PSN | 43d51c1d-5f5b-4b9e-95d0-d12ceff8d84e | 3 |
| 313412 | tizanidine 2 MG Oral Tablet | SCD | 43d51c1d-5f5b-4b9e-95d0-d12ceff8d84e | 3 |
| 313413 | tizanidine 4 MG Oral Tablet | SCD | 43d51c1d-5f5b-4b9e-95d0-d12ceff8d84e | 3 |
| 313412 | tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral Tablet | SY | 43d51c1d-5f5b-4b9e-95d0-d12ceff8d84e | 3 |
| 313413 | tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Tablet | SY | 43d51c1d-5f5b-4b9e-95d0-d12ceff8d84e | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0185-0034-10 | 00185003410 | 1000 TABLET in 1 BOTTLE (0185-0034-10) | 1000 tablet | 2002-11-26 | 2021-05-31 | No | No | Current |
| 0185-0034-51 | 00185003451 | 150 TABLET in 1 BOTTLE (0185-0034-51) | 150 tablet | 2002-11-26 | 2022-03-31 | No | No | Current |