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United States · US · US:68083-146_3a747235-2a80-4d63-bbbf-d81538daf99a
Meropenem
Orange BookUNIISPLATC J01DH02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeJ01DH02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680831461010 VIAL in 1 CARTON (68083-146-10) / 20 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
FV9J3JU8B1
MEROPENEM
RxCUI 29561
Orange Book
A206141
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "FV9J3JU8B1",
"rxcui": "29561",
"inchikey": "CTUAQTBUVLKNDJ-OBZXMJSBSA-N",
"display_name": "MEROPENEM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"e8848f4a-bca9-4978-b0a1-38483fd4d639": {
"match": "brand_token",
"title": "MEROPENEM INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]",
"spl_version": "2",
"published_date": "2026-04-30"
}
},
"productid": "68083-146_3a747235-2a80-4d63-bbbf-d81538daf99a",
"productndc": "68083-146",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "206141",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "500MG/VIAL",
"product_no": "001",
"approval_date": "Jun 8, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1GM/VIAL",
"product_no": "002",
"approval_date": "Jun 8, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MEROPENEM",
"proprietary_name": "Meropenem",
"active_ingred_unit": "mg/20mL",
"application_number": "ANDA206141",
"marketing_category": "ANDA",
"nonproprietary_name": "Meropenem",
"start_marketing_date": "20170428",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code J01DH02.
- CZARCHIFARMedochemie Bohemia, spol. s r.o., Praha
- CZARCHIFARMedochemie Bohemia, spol. s r.o., Praha
- CZARCHIFARMedochemie Bohemia, spol. s r.o., Praha
- CZARCHIFARMedochemie Bohemia, spol. s r.o., Praha
- CZARCHIFARMedochemie Bohemia, spol. s r.o., Praha
- CZARCHIFARMedochemie Bohemia, spol. s r.o., Praha
- CZARCHIFARMedochemie Bohemia, spol. s r.o., Praha
- CZARCHIFARMedochemie Bohemia, spol. s r.o., Praha
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