INVANZ

Product NDC
0006-3843
11-digit product format
000063843
Labeler code
0006
Product ID
0006-3843_42e12d72-1d2d-4b7d-ac4f-4e97b344bcd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ertapenem sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Merck Sharp & Dohme LLC
Application
NDA021337
Marketing category
NDA
Marketing start
2001-11-21
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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021337-001INVANZEQ 1GM BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAPRLD, RS2001-11-21caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N021337-001AP1caaa826d4ba7…
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…

Additional Listing Data#

Finished product
Yes
Brand name base
INVANZ
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1734683Internal RxNorm lookup
1734686Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
33f3b99b-fa82-42e0-26bf-f49891ae3d22Available 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
0006-3843-71INVANZ1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,142
0006-3843-71INVANZ10 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,1042

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-3843-71EA - Each0006-384322268b5d-4fde-4b4b-8acb-214cffd747cb12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-3843INVANZ (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC]38Current NDC, Legacy NDC, 2 package rows20240217_33f3b99b-fa82-42e0-26bf-f49891ae3d22.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
ERTAPENEMERTAPENEM SODIUMENDO USA, Inc.657855f2-7c92-4aa8-9c3d-51d08e56a09a2026-03-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 021337
application number: NDA021337
INVANZERTAPENEM SODIUMMerck Sharp & Dohme LLC33f3b99b-fa82-42e0-26bf-f49891ae3d222026-02-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 021337
application number: NDA021337
ndc (product): 0006-3843

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734683ertapenem sodium 1 GM InjectionPSN33f3b99b-fa82-42e0-26bf-f49891ae3d2242
1734686INVANZ 1 GM InjectionPSN33f3b99b-fa82-42e0-26bf-f49891ae3d2242
1734686ertapenem 1000 MG Injection [Invanz]SBD33f3b99b-fa82-42e0-26bf-f49891ae3d2242
1734683ertapenem 1000 MG InjectionSCD33f3b99b-fa82-42e0-26bf-f49891ae3d2242
1734683ertapenem (as ertapenem sodium 1.046 GM) InjectionSY33f3b99b-fa82-42e0-26bf-f49891ae3d2242
1734683ertapenem 1 GM InjectionSY33f3b99b-fa82-42e0-26bf-f49891ae3d2242
1734686Invanz 1 GM InjectionSY33f3b99b-fa82-42e0-26bf-f49891ae3d2242
1734686Invanz 1000 MG InjectionSY33f3b99b-fa82-42e0-26bf-f49891ae3d2242

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0006-3843-710000638437110 VIAL, SINGLE-DOSE in 1 PACKAGE (0006-3843-71) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2001-11-210000-00-00NoNoCurrent