Home NDC 51810-504 Ertapenem
Product NDC 51810-504
11-digit product format 518100504
Labeler code 51810
Product ID 51810-504_495048da-42bf-465b-bea5-57455ae23197
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ertapenem sodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Qilu Antibiotics Pharmaceutical Co., Ltd.
Application ANDA218067
Marketing category ANDA
Marketing start 2024-10-31
Substance ERTAPENEM SODIUM
Active strength 1 g/1
Pharmacologic classes Carbapenems [CS], Penem Antibacterial [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218067-001 ERTAPENEM SODIUM ERTAPENEM SODIUM EQ 1GM BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AP 2024-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218067-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218067-001 ERTAPENEM SODIUM EQ 1GM BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AP 2024-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218067-001 ERTAPENEM SODIUM EQ 1GM BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AP 2024-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218067-001 ERTAPENEM SODIUM EQ 1GM BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AP 2024-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218067-001 ERTAPENEM SODIUM EQ 1GM BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AP 2024-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218067-001 ERTAPENEM SODIUM EQ 1GM BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AP 2024-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218067-001 ERTAPENEM SODIUM EQ 1GM BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AP 2024-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218067-001 ERTAPENEM SODIUM EQ 1GM BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AP 2024-10-31 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218067-001 ERTAPENEM SODIUM EQ 1GM BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AP 2024-10-31 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218067-001 ERTAPENEM SODIUM EQ 1GM BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AP 2024-10-31 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ertapenem
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ERTAPENEM SODIUM 1 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2T90KE67L0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1734683 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51810-504-01 Ertapenem 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 7 51810-504-02 Ertapenem 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51810-504 ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [QILU ANTIBIOTICS PHARMACEUTICAL CO., LTD.] 2 Current NDC, 2 package rows 20250221_44496f7c-8407-4765-9cd6-1daa619a6db6.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 51810-504-01 51810050401 1 in 1 VIAL, SINGLE-DOSE Historical 51810-504-02 51810050402 10 VIAL, SINGLE-DOSE in 1 CARTON (51810-504-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (51810-504-01) 2024-10-31 No No Current