Midazolam hydrochloride
- Product NDC
- 55648-764
- 11-digit product format
- 556480764
- Labeler code
- 55648
- Product ID
- 55648-764_cc33c428-6db9-428c-8f4d-f575f27b60b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midazolam hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Wockhardt Limited
- Application
- ANDA078511
- Marketing category
- ANDA
- Marketing start
- 2008-11-10
- Marketing end
- 0000-00-00
- Substance
- MIDAZOLAM HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1d526338-43ba-4cef-8730-5a757122f8ce | Product name | 1 | 20260218 |
| 8118475d-d61b-4326-b353-56e9cf8c8d9f | Product name | 3 | 20260218 |
| f69f3735-bf62-03e6-cc7a-5af4af89ec8a | Product name | 5 | 20250516 |
| 4cc03496-da49-494d-b71d-757fe6737fa2 | Product name | 1 | 20230717 |
| 06641162-4d53-492d-8ff2-5951a469060f | Product name | 1 | 20230420 |
| 46ca420c-e4d5-4e6c-9b2f-cea269a262e8 | Product name | 1 | 20230320 |
| b84efe2b-3f4e-4b09-90f9-1d24a61ec30e | Product name | 1 | 20190808 |
| bb7f99f4-8b2b-42a4-8f5a-fcf7dc204f16 | Product name | 1 | 20181220 |
| 31f18c4e-1938-700a-43de-b9e218c36edc | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55648-764-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e3ab-f424-e053-dadaa90a57ce | MIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV |
| 55648-764-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e3ab-f424-e053-dadaa90a57ce | MIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV |
| 55648-764-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e3ab-f424-e053-dadaa90a57ce | MIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV |
| 55648-764-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e3ab-f424-e053-dadaa90a57ce | MIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55648-764-01 | Midazolam hydrochloride | 10 in 1 CARTON | INJECTION | 10 | 1 | |
| 55648-764-02 | Midazolam hydrochloride | 10 in 1 CARTON | INJECTION | 10 | 1 | |
| 55648-764-03 | Midazolam hydrochloride | 25 in 1 CARTON | INJECTION | 25 | 1 | |
| 55648-764-04 | Midazolam hydrochloride | 25 in 1 CARTON | INJECTION | 25 | 1 | |
| 55648-764-05 | Midazolam hydrochloride | 2 mL in 1 VIAL | INJECTION | 2 | 1 | |
| 55648-764-06 | Midazolam hydrochloride | 5 mL in 1 VIAL | INJECTION | 5 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MIDAZOLAM HYDROCHLORIDE | ACTIVE INGREDIENT | W7TTW573JJ | MIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED] | 1 | |
| MIDAZOLAM | ACTIVE MOIETY | R60L0SM5BC | MIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | MIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | MIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | MIDAZOLAM HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1666823 | midazolam 10 MG in 2 ML Injection | PSN | c94e8384-28b1-4668-95fe-3202497490ae | 1 |
| 1666798 | midazolam 2 MG in 2 ML Injection | PSN | c94e8384-28b1-4668-95fe-3202497490ae | 1 |
| 1666814 | midazolam 5 MG in 1 ML Injection | PSN | c94e8384-28b1-4668-95fe-3202497490ae | 1 |
| 1666800 | midazolam 5 MG in 5 ML Injection | PSN | c94e8384-28b1-4668-95fe-3202497490ae | 1 |
| 1666814 | 1 ML midazolam 5 MG/ML Injection | SCD | c94e8384-28b1-4668-95fe-3202497490ae | 1 |
| 1666798 | 2 ML midazolam 1 MG/ML Injection | SCD | c94e8384-28b1-4668-95fe-3202497490ae | 1 |
| 1666823 | 2 ML midazolam 5 MG/ML Injection | SCD | c94e8384-28b1-4668-95fe-3202497490ae | 1 |
| 1666800 | 5 ML midazolam 1 MG/ML Injection | SCD | c94e8384-28b1-4668-95fe-3202497490ae | 1 |
| 1666814 | midazolam (as midazolam hydrochloride) 5 MG per 1 ML Injection | SY | c94e8384-28b1-4668-95fe-3202497490ae | 1 |
| 1666823 | midazolam 10 MG per 2 ML Injection | SY | c94e8384-28b1-4668-95fe-3202497490ae | 1 |
| 1666798 | midazolam 2 MG per 2 ML Injection | SY | c94e8384-28b1-4668-95fe-3202497490ae | 1 |
| 1666800 | midazolam 5 MG per 5 ML Injection | SY | c94e8384-28b1-4668-95fe-3202497490ae | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 55648-764-01 | 55648076401 | 10 in 1 CARTON | Historical | |
| 55648-764-02 | 55648076402 | 10 in 1 CARTON | Historical | |
| 55648-764-03 | 55648076403 | 25 in 1 CARTON | Historical | |
| 55648-764-04 | 55648076404 | 25 in 1 CARTON | Historical | |
| 55648-764-05 | 55648076405 | 2 mL in 1 VIAL | 2 ml | Historical |
| 55648-764-06 | 55648076406 | 5 mL in 1 VIAL | 5 ml | Historical |