Midazolam
- Product NDC
- 0641-6057
- 11-digit product format
- 006416057
- Labeler code
- 0641
- Product ID
- 0641-6057_559c03fb-24ea-4b7b-8afd-e33cb3a2340a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midazolam
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA075243
- Marketing category
- ANDA
- Marketing start
- 2000-06-20
- Substance
- MIDAZOLAM HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Midazolam
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MIDAZOLAM HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | W7TTW573JJ |
| Rxcui | 311700, 311702 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0641-6057-01 | Midazolam | 2 mL in 1 VIAL | INJECTION | 2 | 8 | |
| 0641-6057-10 | Midazolam | 10 in 1 CARTON | INJECTION | 10 | 8 | |
| 0641-6057-25 | Midazolam | 25 in 1 CARTON | INJECTION | 25 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-6057-01 | ML - Milliliter | 0641-6057 | dba6b846-b295-4344-a490-f5f755122ce5 | 1 | 2012-07-24 |
| 0641-6057-10 | ML - Milliliter | 0641-6057 | 76c0684d-8e75-4c1d-aba3-38fbb3ba558c | 1 | 2012-07-24 |
| 0641-6057-25 | ML - Milliliter | 0641-6057 | 51bcdbbb-6d96-4b38-87db-655d1279f3f6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| MIDAZOLAM HYDROCHLORIDE | ACTIVE INGREDIENT | W7TTW573JJ | MIDAZOLAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 2 | |
| MIDAZOLAM | ACTIVE MOIETY | R60L0SM5BC | MIDAZOLAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 2 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | MIDAZOLAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 2 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | MIDAZOLAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | MIDAZOLAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | MIDAZOLAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | MIDAZOLAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | MIDAZOLAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311700 | midazolam 1 MG/ML Injectable Solution | PSN | 575d8bf0-7af7-427c-a231-966e2a5e070d | 8 |
| 311702 | midazolam 5 MG/ML Injectable Solution | PSN | 575d8bf0-7af7-427c-a231-966e2a5e070d | 8 |
| 311700 | midazolam 1 MG/ML Injectable Solution | SCD | 575d8bf0-7af7-427c-a231-966e2a5e070d | 8 |
| 311702 | midazolam 5 MG/ML Injectable Solution | SCD | 575d8bf0-7af7-427c-a231-966e2a5e070d | 8 |
| 311700 | midazolam (as midazolam hydrochloride) 1 MG/ML Injectable Solution | SY | 575d8bf0-7af7-427c-a231-966e2a5e070d | 8 |
| 311702 | midazolam (as midazolam hydrochloride) 5 MG/ML Injectable Solution | SY | 575d8bf0-7af7-427c-a231-966e2a5e070d | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0641-6057-01 | 00641605701 | 2 mL in 1 VIAL | 2 ml | Historical | ||||
| 0641-6057-10 | 00641605710 | 10 VIAL in 1 CARTON (0641-6057-10) / 2 mL in 1 VIAL (0641-6057-01) | 10 vial | 2000-06-20 | 0000-00-00 | No | No | Current |
| 0641-6057-25 | 00641605725 | 25 VIAL in 1 CARTON (0641-6057-25) / 2 mL in 1 VIAL (0641-6057-01) | 25 vial | 2000-06-20 | 0000-00-00 | No | No | Current |