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United States · US · US:55150-282_250abb8f-6547-4f69-94c3-87917dc34240
Ertapenem
Orange BookUNIISPLATC J01DH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEugia US LLC
CountryUS (United States)
ATC codeJ01DH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11551502822010 VIAL, SINGLE-DOSE in 1 CARTON (55150-282-20) / 1 INJECTION in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
2T90KE67L0
ERTAPENEM SODIUM
RxCUI 353107
Orange Book
A209133
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2T90KE67L0",
"rxcui": "353107",
"inchikey": "ZXNAQFZBWUNWJM-HRXMHBOMSA-M",
"display_name": "ERTAPENEM SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS",
"spl_meta": {
"657855f2-7c92-4aa8-9c3d-51d08e56a09a": {
"match": "brand_token",
"title": "ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.]",
"spl_version": "13",
"published_date": "2026-04-09"
}
},
"productid": "55150-282_250abb8f-6547-4f69-94c3-87917dc34240",
"productndc": "55150-282",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "209133",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 1GM BASE/VIAL",
"product_no": "001",
"approval_date": "Jun 25, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ERTAPENEM SODIUM",
"proprietary_name": "Ertapenem",
"active_ingred_unit": "g/1",
"application_number": "ANDA209133",
"marketing_category": "ANDA",
"nonproprietary_name": "Ertapenem",
"start_marketing_date": "20180625",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code J01DH03.
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