ZIMHI
- Product NDC
- 84571-140
- 11-digit product format
- 845710140
- Labeler code
- 84571
- Product ID
- 84571-140_4525b96b-5ab9-b8fd-e063-6294a90aa699
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; SUBCUTANEOUS
- Labeler
- ZMI Pharma Inc.
- Application
- NDA212854
- Marketing category
- NDA
- Marketing start
- 2022-01-15
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- 5 mg/.5mL
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ZIMHI
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NALOXONE HYDROCHLORIDE | 5 mg/.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F850569PQR |
| Rxcui | 2589612, 2589618 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84571-140-02 | ZIMHI | 1 in 1 CASE | INJECTION, SOLUTION | 1 | | 3 |
| 84571-140-02 | ZIMHI | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 3 |
| 84571-140-11 | ZIMHI | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
| 84571-140-11 | ZIMHI | 1 in 1 CASE | INJECTION, SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 84571-140 | ZIMHI (NALOXONE HYDROCHLORIDE) INJECTION, SOLUTION [ZMI PHARMA INC.] | 2 | Current NDC, 4 package rows | 20241123_523c0909-bff6-4010-988a-53de18b7cb3f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84571-140-02 | 84571014002 | 2 CASE in 1 CARTON (84571-140-02) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE | 2 case | 2022-01-15 | No | No | Current |
| 84571-140-11 | 84571014011 | 1 CASE in 1 CARTON (84571-140-11) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE | 1 case | 2022-01-15 | No | No | Current |