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United States · US · US:71053-595_4b1cba4c-3cc1-5642-e063-6294a90a4522
N/A
In shortageOrange BookUNIISPLATC N05CD08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRafa Laboratories, Ltd.
CountryUS (United States)
ATC codeN05CD08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117105359501480 CARTON in 1 BOX (71053-595-01) / 40 SYRINGE in 1 CARTON / .7 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
R60L0SM5BC
MIDAZOLAM
RxCUI 6960
Orange Book
N216359
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Midazolam Hydrochloride Injection
Raw payload (JSON)
{
"unii": {
"unii": "R60L0SM5BC",
"rxcui": "6960",
"inchikey": "DDLIGBOFAVUZHB-UHFFFAOYSA-N",
"display_name": "MIDAZOLAM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR",
"spl_meta": {
"4a4fa6e8-0e0a-0e76-e054-00144ff8d46c": {
"match": "brand_token",
"title": "N/A (ATROPINE SULFATE INJECTION USP, 1 MG/0.7 ML) INJECTION N/A (ATROPINE SULFATE INJECTION USP, 0.5 MG/0.7 ML) INJECTION N/A (ATROPINE INJECTION, 2 MG) INJECTION [RAFA LABORATORIES, LTD.]",
"spl_version": "8",
"published_date": "2026-02-19"
}
},
"productid": "71053-595_4b1cba4c-3cc1-5642-e063-6294a90a4522",
"productndc": "71053-595",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "216359",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)",
"product_no": "001",
"approval_date": "Aug 8, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MIDAZOLAM",
"shortage_reason": "Midazolam Hydrochloride Injection",
"shortage_status": "current",
"proprietary_name": "N/A",
"active_ingred_unit": "mg/.7mL",
"application_number": "NDA216359",
"marketing_category": "NDA",
"nonproprietary_name": "Midazolam Injection, 10 mg",
"start_marketing_date": "20220808",
"active_numerator_strength": "10"
}Related drugs
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