Home NDC 68001-408-31 Ertapenem
Product NDC 68001-408
Requested package NDC 68001-408-31
11-digit product format 680010408
Labeler code 68001
Product ID 68001-408_12e7c27b-9d21-bf94-e063-6294a90aedcf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ertapenem Sodium
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler BluePoint Laboratories
Application ANDA207647
Marketing category ANDA
Marketing start 2019-08-29
Substance ERTAPENEM SODIUM
Active strength 1 g/20mL
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 A207647-001 ERTAPENEM SODIUM ERTAPENEM SODIUM EQ 1GM BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AP 2019-03-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207647-001 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 2026-08-01 22:54:32 2026-06 A207647-001 ERTAPENEM SODIUM EQ 1GM BASE/VIAL INJECTABLE / INTRAMUSCULAR, INTRAVENOUS AP 2019-03-19 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A207647-001 AP 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
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/20mL
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 68001-408-29 Ertapenem 20 mL in 1 VIAL INJECTION 20 5 68001-408-31 Ertapenem 10 in 1 CARTON INJECTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68001-408 ERTAPENEM (ERTAPENEM SODIUM) INJECTION [BLUEPOINT LABORATORIES] 5 Current NDC, Legacy NDC, 2 package rows 20240306_8eccc96f-4b59-49ee-9997-365a24f59a24.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68001-408-31 68001040831 10 VIAL in 1 CARTON (68001-408-31) / 20 mL in 1 VIAL (68001-408-29) 10 vial 2019-08-29 0000-00-00 No No Current