tizanidine hydrochloride
- Product NDC
- 63629-5139
- 11-digit product format
- 636295139
- Labeler code
- 63629
- Product ID
- 63629-5139_b703f118-c09d-41a3-b256-d2edd16350c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tizanidine hydrochloride
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- NDA021447
- Marketing category
- NDA
- Marketing start
- 2012-02-06
- Marketing end
- 0000-00-00
- Substance
- TIZANIDINE HYDROCHLORIDE
- Active strength
- 6 mg/1
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TIZANIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | B53E3NMY5C | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK] | 1000 | |
| TIZANIDINE | ACTIVE MOIETY | 6AI06C00GW | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK] | 1000 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK] | 1000 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK] | 1000 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK] | 1000 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK] | 1000 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK] | 1000 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK] | 1000 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-5139 | TIZANIDINE HYDROCHLORIDE CAPSULE, GELATIN COATED [BRYANT RANCH PREPACK] | 1002 | Legacy NDC | 20240518_b703f118-c09d-41a3-b256-d2edd16350c8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-5139-1 | 63629513901 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (63629-5139-1) | 2015-04-23 | 0000-00-00 | No | No | Current |
| 63629-5139-2 | 63629513902 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (63629-5139-2) | 2013-11-12 | 0000-00-00 | No | No | Current |
| 63629-5139-3 | 63629513903 | 90 CAPSULE, GELATIN COATED in 1 BOTTLE (63629-5139-3) | 2013-11-12 | 0000-00-00 | No | No | Current |
| 63629-5139-4 | 63629513904 | 120 CAPSULE, GELATIN COATED in 1 BOTTLE (63629-5139-4) | 2022-02-15 | 0000-00-00 | No | No | Current |
| 63629-5139-5 | 63629513905 | 28 CAPSULE, GELATIN COATED in 1 BOTTLE (63629-5139-5) | 2022-02-15 | 0000-00-00 | No | No | Current |