Midazolam
- Product NDC
- 0641-6219
- 11-digit product format
- 006416219
- Labeler code
- 0641
- Product ID
- 0641-6219_c7078d4a-0f37-4305-b20c-0a8f17382963
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midazolam
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA212847
- Marketing category
- ANDA
- Marketing start
- 2024-03-29
- 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 |
|---|---|---|---|---|---|---|
| 0641-6219-01 | Midazolam | 2 mL in 1 SYRINGE | INJECTION | 2 | 4 | |
| 0641-6219-10 | Midazolam | 10 in 1 CARTON | INJECTION | 10 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-6219-01 | ML - Milliliter | 0641-6219 | 163034d0-67b7-4b0b-8d8d-e262746f221b | 1 | 2024-04-05 |
| 0641-6219-10 | ML - Milliliter | 0641-6219 | 6823ccb1-a818-4d14-8b06-c94c6809b0eb | 1 | 2024-04-05 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1551393 | midazolam 10 MG in 2 ML Prefilled Syringe | PSN | 51c8bfa4-5c78-4b7a-9ffb-8f00828acadc | 4 |
| 998211 | midazolam 2 MG in 2 ML Prefilled Syringe | PSN | 51c8bfa4-5c78-4b7a-9ffb-8f00828acadc | 4 |
| 1551395 | midazolam 5 MG in 1 ML Prefilled Syringe | PSN | 51c8bfa4-5c78-4b7a-9ffb-8f00828acadc | 4 |
| 1551395 | 1 ML midazolam 5 MG/ML Prefilled Syringe | SCD | 51c8bfa4-5c78-4b7a-9ffb-8f00828acadc | 4 |
| 998211 | 2 ML midazolam 1 MG/ML Prefilled Syringe | SCD | 51c8bfa4-5c78-4b7a-9ffb-8f00828acadc | 4 |
| 1551393 | 2 ML midazolam 5 MG/ML Prefilled Syringe | SCD | 51c8bfa4-5c78-4b7a-9ffb-8f00828acadc | 4 |
| 1551393 | midazolam (as midazolam hydrochloride) 10 MG per 2 ML Prefilled Syringe | SY | 51c8bfa4-5c78-4b7a-9ffb-8f00828acadc | 4 |
| 998211 | midazolam (as midazolam hydrochloride) 2 MG per 2 ML Prefilled Syringe | SY | 51c8bfa4-5c78-4b7a-9ffb-8f00828acadc | 4 |
| 1551395 | midazolam (as midazolam hydrochloride) 5 MG per 1 ML Prefilled Syringe | SY | 51c8bfa4-5c78-4b7a-9ffb-8f00828acadc | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0641-6219-01 | 00641621901 | 2 mL in 1 SYRINGE | 2 ml | Historical | |||
| 0641-6219-10 | 00641621910 | 10 SYRINGE in 1 CARTON (0641-6219-10) / 2 mL in 1 SYRINGE (0641-6219-01) | 10 syringe | 2024-03-29 | No | No | Historical |