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United States · US · US:0143-9398_0563c487-5b62-46fe-a7e3-8ade454f1f4f
ertapenem sodium
Orange BookUNIISPLATC J01DH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeJ01DH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11014393981010 VIAL, SINGLE-DOSE in 1 CARTON (0143-9398-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9398-01)
Annotations
UNII (FDA Substance ID)
2T90KE67L0
ERTAPENEM SODIUM
RxCUI 353107
Orange Book
A208790
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": "0143-9398_0563c487-5b62-46fe-a7e3-8ade454f1f4f",
"productndc": "0143-9398",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "208790",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 1GM BASE/VIAL",
"product_no": "001",
"approval_date": "Apr 16, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ERTAPENEM SODIUM",
"proprietary_name": "ertapenem sodium",
"active_ingred_unit": "g/1",
"application_number": "ANDA208790",
"marketing_category": "ANDA",
"nonproprietary_name": "ertapenem sodium",
"start_marketing_date": "20210802",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code J01DH03.
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