Tobramycin and Dexamethasone

Product NDC
55700-915
11-digit product format
557000915
Labeler code
55700
Product ID
55700-915_7c42ae6e-18f1-460a-81a3-d59aba84e8da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin and Dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Quality Care Products, LLC
Application
ANDA064134
Marketing category
ANDA
Marketing start
2021-07-08
Marketing end
0000-00-00
Substance
DEXAMETHASONE; TOBRAMYCIN
Active strength
1 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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-915-052025-01-13C16284748780-11030e365-64d3-111a-e063-dadaa90a10e200b94592-a8c4-4fb5-883f-661583f5509d
55700-915-052024-01-30C16284748780-11030e365-64d3-111a-e063-dadaa90a10e200b94592-a8c4-4fb5-883f-661583f5509d

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-915-05ML - Milliliter55700-915e3e18b5d-456d-41ef-982c-989b6028f55c12021-08-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-915-05557000915051 BOTTLE, DROPPER in 1 CARTON (55700-915-05) > 5 mL in 1 BOTTLE, DROPPER2021-07-080000-00-00NoNoCurrent