FDA.reportPublic FDA data

TOBRAMYCIN AND DEXAMETHASONE

Product NDC
63629-9570
11-digit product format
636299570
Labeler code
63629
Product ID
63629-9570_73c0e986-6345-4530-be51-cf6ac0027743
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tobramycin and dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Bryant Ranch Prepack
Application
ANDA212715
Marketing category
ANDA
Marketing start
2022-03-17
Substance
DEXAMETHASONE; TOBRAMYCIN
Active strength
1; 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 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
A212715-001TOBRAMYCIN AND DEXAMETHASONEDEXAMETHASONE; TOBRAMYCIN0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212715-001AB

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
2026-02-19 14:30 UTC2026-02A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-114b0b4de00fa7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212715-001TOBRAMYCIN AND DEXAMETHASONE0.1%;0.3%SUSPENSION/DROPS / OPHTHALMICAB2022-02-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212715-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212715-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212715-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212715-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212715-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212715-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212715-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212715-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212715-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212715-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212715-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212715-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212715-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212715-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212715-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212715-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212715-001AB14b0b4de00fa7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212715-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212715-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212715-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212715-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212715-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212715-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212715-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A212715-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A212715-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212715-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212715-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212715-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212715-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212715-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
TOBRAMYCIN AND DEXAMETHASONE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOBRAMYCIN1 mg/mL
DEXAMETHASONE3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VZ8RRZ51VKInternal UNII lookup
7S5I7G3JQLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309683Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c63c481-ce57-41ca-993f-5a5b665fa1e4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
f297c7c1-845a-4369-8c02-c51b92d6ae8eProduct name320240725
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
551d952d-4ce2-24f0-9ab0-630ad9aae596Product name220231211
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
9cfa145f-dbe9-bc02-83c2-692786ef6676Product name920210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796Product name420210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277Product name420210625
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
9f5124fb-08b0-4c3e-8e12-a1a6ff310cbaProduct name120150309
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
745a62af-e1c0-4ca3-6d6e-2b6455b903beProduct name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508
ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9570-1TOBRAMYCIN AND DEXAMETHASONE2.5 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS2.5103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9570-1ML - Milliliter63629-9570a2f934d3-452e-43f4-99aa-16871e1ff86d12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9570TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240113_3c63c481-ce57-41ca-993f-5a5b665fa1e4.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepackdf4a7747-8dfa-4933-b4d2-a3d85c5f74f82026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212715
application number: ANDA212715
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack1884ef6f-a60c-4a82-a7dc-fd48b7176db02026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212715
application number: ANDA212715
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONERedpharm Drug3dd00c21-ae42-0613-e063-6394a90a80122025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212715
application number: ANDA212715
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack3e541ebf-2f7e-4cc0-9928-780353aa76572025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212715
application number: ANDA212715
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack3e5cd7f9-1f88-4d33-be25-c362de4dc87b2025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212715
application number: ANDA212715
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack15280680-edc0-4e5d-99ee-117a6f5893072025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212715
application number: ANDA212715
Tobramycin and dexamethasoneTOBRAMYCIN AND DEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLCf4c00d9c-3a17-06a0-e053-2a95a90a84132024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212715
application number: ANDA212715
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEA-S Medication Solutions8d6a8a22-fd97-43e7-a89c-b1f32710a7732024-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212715
application number: ANDA212715
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepacka5f0b05b-3dec-4fe8-8106-e41e668a512d2024-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212715
application number: ANDA212715
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack3c63c481-ce57-41ca-993f-5a5b665fa1e42024-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212715
application number: ANDA212715
ndc (product): 63629-9570
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEPadagis US LLC7e34b1a9-8d21-41db-9070-37227975414f2023-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212715
application number: ANDA212715

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309683tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic SuspensionPSN3c63c481-ce57-41ca-993f-5a5b665fa1e4103
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD3c63c481-ce57-41ca-993f-5a5b665fa1e4103
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY3c63c481-ce57-41ca-993f-5a5b665fa1e4103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9570-1636299570012.5 mL in 1 BOTTLE, PLASTIC (63629-9570-1) 2.5 ml2022-12-210000-00-00NoNoCurrent