FDA.reportPublic FDA data

ZAYNICH

Product NDC
87706-866
11-digit product format
877060866
Labeler code
87706
Product ID
87706-866_5381b2e7-e719-2af8-e063-6294a90a2732
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zidebactam dihydrate and cefepime hydrochloride
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Wockhardt Suisse USA LLC
Application
NDA220787
Marketing category
NDA
Marketing start
2026-05-29
Substance
ZIDEBACTAM DIHYDRATE; CEFEPIME HYDROCHLORIDE
Active strength
1; 2 g/1; g/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
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 43.

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
N220787-001ZAYNICHCEFEPIME HYDROCHLORIDE; ZIDEBACTAMEQ 2GM BASE/VIAL;1GM/VIALPOWDER / INTRAVENOUSRLD, RS2026-05-29

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N220787-00188224502032-08-24Drug substance, Drug product2026-06-15
N220787-00188531972032-08-24Drug substance2026-06-15
N220787-00191321332032-08-24U-45582026-06-15
N220787-00193812002032-08-24Drug product2026-06-15
N220787-00198272352032-08-24U-4558Drug product2026-06-15
N220787-00196570212033-10-12Drug substance2026-06-15
N220787-00198345572033-10-12Drug substance2026-06-15

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N220787-001NCE2031-05-29
N220787-001GAIN2036-05-29

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N220787-001ZAYNICHEQ 2GM BASE/VIAL;1GM/VIALPOWDER / INTRAVENOUSRLD, RS2026-05-2984e616aacf4f…
2026-08-18 06:07:402026-07N220787-001ZAYNICHEQ 2GM BASE/VIAL;1GM/VIALPOWDER / INTRAVENOUSRLD, RS2026-05-29caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220787-001ZAYNICHEQ 2GM BASE/VIAL;1GM/VIALPOWDER / INTRAVENOUSRLD, RS2026-05-29a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N220787-00188224502032-08-24Drug substance, Drug product2026-06-1584e616aacf4f…
2026-09-14 22:38:342026-08N220787-00188531972032-08-24Drug substance2026-06-1584e616aacf4f…
2026-09-14 22:38:342026-08N220787-00191321332032-08-24U-45582026-06-1584e616aacf4f…
2026-09-14 22:38:342026-08N220787-00193812002032-08-24Drug product2026-06-1584e616aacf4f…
2026-09-14 22:38:342026-08N220787-00198272352032-08-24U-4558Drug product2026-06-1584e616aacf4f…
2026-09-14 22:38:342026-08N220787-00196570212033-10-12Drug substance2026-06-1584e616aacf4f…
2026-09-14 22:38:342026-08N220787-00198345572033-10-12Drug substance2026-06-1584e616aacf4f…
2026-08-18 06:07:402026-07N220787-00188224502032-08-24Drug substance, Drug product2026-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07N220787-00188531972032-08-24Drug substance2026-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07N220787-00191321332032-08-24U-45582026-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07N220787-00193812002032-08-24Drug product2026-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07N220787-00198272352032-08-24U-4558Drug product2026-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07N220787-00196570212033-10-12Drug substance2026-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07N220787-00198345572033-10-12Drug substance2026-06-15caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220787-00188224502032-08-24Drug substance, Drug product2026-06-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220787-00188531972032-08-24Drug substance2026-06-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220787-00191321332032-08-24U-45582026-06-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220787-00193812002032-08-24Drug product2026-06-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220787-00198272352032-08-24U-4558Drug product2026-06-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220787-00196570212033-10-12Drug substance2026-06-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220787-00198345572033-10-12Drug substance2026-06-15a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N220787-001NCE2031-05-2984e616aacf4f…
2026-09-14 22:38:342026-08N220787-001GAIN2036-05-2984e616aacf4f…
2026-08-18 06:07:402026-07N220787-001NCE2031-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07N220787-001GAIN2036-05-29caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220787-001NCE2031-05-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220787-001GAIN2036-05-29a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZIDEBACTAM DIHYDRATE1 g/1
CEFEPIME HYDROCHLORIDE2 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TE54T8WC4TInternal UNII lookup
I8X1O0607PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2744819Internal RxNorm lookup
2744824Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c84e652e-5e76-4568-8812-bd5fa34803b6Available on FDA.report

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZAYNICHZIDEBACTAM DIHYDRATE AND CEFEPIME HYDROCHLORIDEWockhardt Suisse USA LLCc84e652e-5e76-4568-8812-bd5fa34803b62026-06-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 220787
application number: NDA220787
ndc (product): 87706-866

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
87706-866-01877060866011 VIAL, SINGLE-DOSE in 1 CARTON (87706-866-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (87706-866-00) 2026-05-29NoNoCurrent