TOBRAMYCIN AND DEXAMETHASONE

Product NDC
63629-9572
11-digit product format
636299572
Labeler code
63629
Product ID
63629-9572_ab233ed9-6d75-4ff3-82fe-c6872fc8a839
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
2027-12-31

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
1884ef6f-a60c-4a82-a7dc-fd48b7176db0Available 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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9cfa145f-dbe9-bc02-83c2-692786ef6676Product name920210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796Product name420210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277Product name420210625
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9f5124fb-08b0-4c3e-8e12-a1a6ff310cbaProduct name120150309
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
745a62af-e1c0-4ca3-6d6e-2b6455b903beProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508
ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9572-1TOBRAMYCIN AND DEXAMETHASONE10 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS10102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9572-1ML - Milliliter63629-957201d1b3a8-0923-443b-acfb-b8102824a3c212023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9572TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240113_1884ef6f-a60c-4a82-a7dc-fd48b7176db0.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
ndc (product): 63629-9572
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
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 SuspensionPSN1884ef6f-a60c-4a82-a7dc-fd48b7176db0103
309683dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCD1884ef6f-a60c-4a82-a7dc-fd48b7176db0103
309683dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic SuspensionSY1884ef6f-a60c-4a82-a7dc-fd48b7176db0103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9572-16362995720110 mL in 1 BOTTLE, PLASTIC (63629-9572-1) 10 ml2022-12-210000-00-00NoNoCurrent