METRONIDAZOLE
- Product NDC
- 0264-5535
- 11-digit product format
- 002645535
- Labeler code
- 0264
- Product ID
- 0264-5535_d16a1d82-f9ec-4c94-a9d6-0ccaba6dca82
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METRONIDAZOLE
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- B. Braun Medical Inc.
- Application
- NDA018900
- Marketing category
- NDA
- Marketing start
- 1983-09-29
- Substance
- METRONIDAZOLE
- Active strength
- 500 mg/100mL
- Pharmacologic classes
- Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- METRONIDAZOLE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METRONIDAZOLE | 500 mg/100mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 140QMO216E |
| Rxcui | 311683 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55 | Product name | 5 | 20251024 |
| 7f6d14e0-4366-41bc-a4a9-b74c79a20e17 | Product name | 1 | 20250623 |
| e6d321b0-0e5e-7da6-f043-92b6a91f00a1 | Product name | 5 | 20250515 |
| e1aac33b-94ae-4ee9-905b-299f7263853b | Product name | 3 | 20250124 |
| 16642716-d28a-4f90-8dcb-3921cd8c8109 | Product name | 4 | 20240516 |
| 0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15 | Product name | 1 | 20240313 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| a5070875-62bb-61e1-fd46-8f7054197a40 | Product name | 8 | 20180215 |
| 0add4de9-d152-3375-3390-1123dddc5e3d | Product name | 1 | 20140508 |
| 33ca0fcc-1011-92dc-50a9-a383683eed1e | Product name | 1 | 20140508 |
| 53f39d9f-cd3f-04e1-c668-d4580719d57d | Product name | 1 | 20140508 |
| a804000f-b74f-0b5d-d17b-aa767c286ddb | Product name | 1 | 20140508 |
| a91ea265-6e02-c08f-93c8-686d54180529 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0264-5535-32 | METRONIDAZOLE | 4 in 1 CARTON | SOLUTION | 4 | 30 | |
| 0264-5535-32 | METRONIDAZOLE | 6 in 1 CASE | SOLUTION | 6 | 30 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0264-5535-32 | ML - Milliliter | 0264-5535 | b70d40a0-64ff-4e45-97e2-2db6990d10ed | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METRONIDAZOLE | ACTIVE INGREDIENT | 140QMO216E | METRONIDAZOLE SOLUTION [B. BRAUN MEDICAL INC.] | 9 | |
| METRONIDAZOLE | ACTIVE MOIETY | 140QMO216E | METRONIDAZOLE SOLUTION [B. BRAUN MEDICAL INC.] | 9 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | METRONIDAZOLE SOLUTION [B. BRAUN MEDICAL INC.] | 9 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | METRONIDAZOLE SOLUTION [B. BRAUN MEDICAL INC.] | 9 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | METRONIDAZOLE SOLUTION [B. BRAUN MEDICAL INC.] | 9 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | METRONIDAZOLE SOLUTION [B. BRAUN MEDICAL INC.] | 9 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311683 | metroNIDAZOLE 500 MG in 100 ML Injection | PSN | fd191c06-9d3b-4e46-9f79-90f6af614947 | 30 |
| 311683 | 100 ML metronidazole 5 MG/ML Injection | SCD | fd191c06-9d3b-4e46-9f79-90f6af614947 | 30 |
| 311683 | metronidazole 500 MG per 100 ML Injection | SY | fd191c06-9d3b-4e46-9f79-90f6af614947 | 30 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0264-5535-32 | 00264553532 | 6 CARTON in 1 CASE (0264-5535-32) / 4 CONTAINER in 1 CARTON / 100 mL in 1 CONTAINER | 6 carton | 1983-09-29 | 0000-00-00 | No | No | Current |