midazolam
- Product NDC
- 25021-661
- 11-digit product format
- 250210661
- Labeler code
- 25021
- Product ID
- 25021-661_002ea282-09ba-4d79-8bd1-94c9859f442b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- midazolam hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA090850
- Marketing category
- ANDA
- Marketing start
- 2012-03-19
- Substance
- MIDAZOLAM HYDROCHLORIDE
- Active strength
- 5 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
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 |
|---|---|---|---|---|---|---|
| 25021-661-10 | midazolam | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | 14 | |
| 25021-661-10 | midazolam | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 25021-661-05 | ML - Milliliter | 25021-661 | 728fb4d7-edf9-4244-a544-cb5f29285342 | 1 | 2012-07-24 |
| 25021-661-10 | ML - Milliliter | 25021-661 | 4e2f0cff-ddbc-4b7a-b859-eb7e899e8ac6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| midazolam hydrochloride | ACTIVE INGREDIENT | W7TTW573JJ | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION [SAGENT PHARMACEUTICALS] | 10 | |
| midazolam | ACTIVE MOIETY | R60L0SM5BC | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION [SAGENT PHARMACEUTICALS] | 10 | |
| benzyl alcohol | INACTIVE INGREDIENT | LKG8494WBH | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION [SAGENT PHARMACEUTICALS] | 10 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION [SAGENT PHARMACEUTICALS] | 10 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION [SAGENT PHARMACEUTICALS] | 10 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) INJECTION [SAGENT PHARMACEUTICALS] | 10 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311702 | midazolam 5 MG/ML Injectable Solution | PSN | 880cac48-5c0f-49a9-8aef-3c9770bf5d84 | 14 |
| 311702 | midazolam 5 MG/ML Injectable Solution | SCD | 880cac48-5c0f-49a9-8aef-3c9770bf5d84 | 14 |
| 311702 | midazolam (as midazolam hydrochloride) 5 MG/ML Injectable Solution | SY | 880cac48-5c0f-49a9-8aef-3c9770bf5d84 | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 25021-661-10 | 25021066110 | 10 VIAL in 1 CARTON (25021-661-10) / 10 mL in 1 VIAL | 10 vial | 2012-03-19 | No | No | Historical |