FDA.reportPublic FDA data

Loteprednol etabonate and Tobramycin

Product NDC
46708-801
11-digit product format
467080801
Labeler code
46708
Product ID
46708-801_a6d68829-f7b6-4b9b-ad44-110c47609918
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loteprednol etabonate and Tobramycin
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA217597
Marketing category
ANDA
Marketing start
2025-12-10
Substance
LOTEPREDNOL ETABONATE; TOBRAMYCIN
Active strength
5; 3 mg/mL; mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 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
A217597-001LOTEPREDNOL ETABONATE AND TOBRAMYCINLOTEPREDNOL ETABONATE; TOBRAMYCIN0.5%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2025-12-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217597-001AB

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A217597-001CGT2026-07-14

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
2026-08-18 06:07:402026-07A217597-001LOTEPREDNOL ETABONATE AND TOBRAMYCIN0.5%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2025-12-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217597-001LOTEPREDNOL ETABONATE AND TOBRAMYCIN0.5%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2025-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217597-001LOTEPREDNOL ETABONATE AND TOBRAMYCIN0.5%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2025-12-1031067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217597-001LOTEPREDNOL ETABONATE AND TOBRAMYCIN0.5%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2025-12-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217597-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217597-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217597-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217597-001AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07A217597-001CGT2026-07-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217597-001CGT2026-07-14011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217597-001CGT2026-07-14a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Loteprednol etabonate and Tobramycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOTEPREDNOL ETABONATE5 mg/mL
TOBRAMYCIN3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YEH1EZ96K6Internal UNII lookup
VZ8RRZ51VKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545255Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6d68829-f7b6-4b9b-ad44-110c47609918Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4f474382-f6ee-e00d-5df3-bba50cddfd89Product name520251114
64ba4d79-5363-eefc-3390-ee5d2a50a350Product name320250304
100e83dc-ec8c-9e2e-76d2-5112415ec972Product name320241008
f297c7c1-845a-4369-8c02-c51b92d6ae8eProduct name320240725
551d952d-4ce2-24f0-9ab0-630ad9aae596Product name220231211
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
9cfa145f-dbe9-bc02-83c2-692786ef6676Product name920210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796Product name420210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277Product name420210625
4300453c-d545-46d1-b115-18b12b4ccf79Product name120210525
3f316f1c-2561-47c9-9865-ba2be69e0b3eProduct name120190614
f1ee2aaf-88da-4841-948b-7d3a6af14e35Product name120181206
9f5124fb-08b0-4c3e-8e12-a1a6ff310cbaProduct name120150309
745a62af-e1c0-4ca3-6d6e-2b6455b903beProduct name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81Product name120140508
b5c5cd73-a27b-5e41-bd36-3de9471473cdProduct name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508
ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-801-05Loteprednol etabonate and Tobramycin1 in 1 CARTONSUSPENSION/ DROPS11
46708-801-05Loteprednol etabonate and Tobramycin5 mL in 1 BOTTLESUSPENSION/ DROPS51
46708-801-10Loteprednol etabonate and Tobramycin1 in 1 CARTONSUSPENSION/ DROPS11
46708-801-10Loteprednol etabonate and Tobramycin10 mL in 1 BOTTLESUSPENSION/ DROPS101

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loteprednol etabonate and TobramycinLOTEPREDNOL ETABONATE AND TOBRAMYCINAlembic Pharmaceuticals Limiteda6d68829-f7b6-4b9b-ad44-110c476099182025-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217597
application number: ANDA217597
ndc (product): 46708-801
Loteprednol etabonate and TobramycinLOTEPREDNOL ETABONATE AND TOBRAMYCINAlembic Pharmaceuticals Inc.7c752fac-8ec8-49ab-8570-09d2aabbeef02025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217597
application number: ANDA217597

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545255loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic SuspensionPSNa6d68829-f7b6-4b9b-ad44-110c476099181
545255loteprednol etabonate 5 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCDa6d68829-f7b6-4b9b-ad44-110c476099181
545255loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic SuspensionSYa6d68829-f7b6-4b9b-ad44-110c476099181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-801-05467080801051 BOTTLE in 1 CARTON (46708-801-05) / 5 mL in 1 BOTTLE1 bottle2025-12-10NoNoCurrent
46708-801-10467080801101 BOTTLE in 1 CARTON (46708-801-10) / 10 mL in 1 BOTTLE1 bottle2025-12-10NoNoCurrent