ERTAPENEM

Product NDC
42023-221
Requested package NDC
42023-221-10
11-digit product format
420230221
Labeler code
42023
Product ID
42023-221_137f9963-a021-47a5-8bb0-2a1621030708
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ertapenem sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
ENDO USA, Inc.
Application
NDA021337
Marketing category
NDA
Marketing start
2018-11-01
Substance
ERTAPENEM SODIUM
Active strength
1 g/1
Pharmacologic classes
Carbapenems [CS], Penem Antibacterial [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021337-001INVANZERTAPENEM SODIUMEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N021337-001AP

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-2187673890dc5c…
2021-03-12 10:30 UTC2021-03N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-213f01610625f2…
2019-09-15 20:21 UTC2019-09N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-213f0d92c62455…
2023-05-13 08:27 UTC2023-05N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21053a50430f4f…
2023-01-26 05:58 UTC2023-01N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021337-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021337-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021337-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021337-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021337-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021337-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021337-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021337-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021337-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021337-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021337-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021337-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021337-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021337-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021337-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021337-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021337-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021337-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021337-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021337-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021337-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N021337-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021337-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021337-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021337-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N021337-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021337-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021337-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021337-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021337-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021337-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021337-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021337-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021337-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021337-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021337-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021337-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021337-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021337-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021337-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
ERTAPENEM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERTAPENEM SODIUM1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2T90KE67L0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1734683Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
41304b1d-7db4-468a-ab1d-04e56fb50de4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aa4e6ef0-aff8-b16d-a7b0-a1baf91ab629Product name620250623
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-221-01ERTAPENEM1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,113
42023-221-10ERTAPENEM10 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,1013
42023-221-85ERTAPENEM10 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,1013
42023-221-89ERTAPENEM1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-221-01EA - Each42023-221ab48327d-4a9d-49ae-93cb-36b2e50be6f212018-08-13
42023-221-10EA - Each42023-2215bce14c2-8926-4eb4-a8cc-2bba14d9ebd912018-08-13
42023-221-85EA - Each42023-221cca54412-b1b8-4749-9c80-0c30149b3ec612018-12-13
42023-221-89EA - Each42023-221014f44b1-2664-42fc-bdd2-c33f5769861b12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-221ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.]10Current NDC, Legacy NDC, 2 package rows20240716_657855f2-7c92-4aa8-9c3d-51d08e56a09a.zip
42023-221ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.]9Current NDC, Legacy NDC, 2 package rows20240716_41304b1d-7db4-468a-ab1d-04e56fb50de4.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ERTAPENEMERTAPENEM SODIUMENDO USA, Inc.41304b1d-7db4-468a-ab1d-04e56fb50de42026-03-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 021337
application number: NDA021337
ndc (product): 42023-221
ERTAPENEMERTAPENEM SODIUMENDO USA, Inc.657855f2-7c92-4aa8-9c3d-51d08e56a09a2026-03-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 021337
application number: NDA021337
ndc (package): 42023-221-10
ndc (product): 42023-221
ndc11 (package): 42023022110
INVANZERTAPENEM SODIUMMerck Sharp & Dohme LLC33f3b99b-fa82-42e0-26bf-f49891ae3d222026-02-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 021337
application number: NDA021337

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734683ertapenem sodium 1 GM InjectionPSN41304b1d-7db4-468a-ab1d-04e56fb50de413
1734683ertapenem sodium 1 GM InjectionPSN657855f2-7c92-4aa8-9c3d-51d08e56a09a13
1734683ertapenem 1000 MG InjectionSCD41304b1d-7db4-468a-ab1d-04e56fb50de413
1734683ertapenem 1000 MG InjectionSCD657855f2-7c92-4aa8-9c3d-51d08e56a09a13
1734683ertapenem (as ertapenem sodium 1.046 GM) InjectionSY41304b1d-7db4-468a-ab1d-04e56fb50de413
1734683ertapenem (as ertapenem sodium 1.046 GM) InjectionSY657855f2-7c92-4aa8-9c3d-51d08e56a09a13
1734683ertapenem 1 GM InjectionSY41304b1d-7db4-468a-ab1d-04e56fb50de413
1734683ertapenem 1 GM InjectionSY657855f2-7c92-4aa8-9c3d-51d08e56a09a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42023-221-104202302211010 VIAL, SINGLE-DOSE in 1 PACKAGE (42023-221-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-221-01) 2018-07-260000-00-00NoNoCurrent