BION TEARS

Product NDC
0065-9305
11-digit product format
000659305
Labeler code
0065
Product ID
0065-9305_99e11df4-015e-41eb-804d-85a3e0e6c5be
Type
HUMAN OTC DRUG
Nonproprietary name
Dextran, Hypromellose
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-01
Substance
DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S)
Active strength
1; 3 mg/mL; mg/mL
Pharmacologic classes
Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BION TEARS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTRAN 701 mg/mL
HYPROMELLOSE 2910 (4000 MPA.S)3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7SA290YK68, RN3152OP35
Rxcui309714, 1088217

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-9305-01BION TEARS28 in 1 CARTONSOLUTION/ DROPS283
0065-9305-01BION TEARS0.4 mL in 1 VIALSOLUTION/ DROPS0.43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-9305-01EA - Each0065-93053b147621-9bde-46b8-aa52-abf670aebd0512023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-9305BION TEARS (DEXTRAN, HYPROMELLOSE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]3Current NDC, 2 package rows20231215_538c2a89-efb5-4132-b678-5a78f23cb713.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1088217BION TEARS 0.1 % / 0.3 % Ophthalmic SolutionPSN538c2a89-efb5-4132-b678-5a78f23cb7133
309714dextran 70 0.1 % / hypromellose 0.3 % Ophthalmic SolutionPSN538c2a89-efb5-4132-b678-5a78f23cb7133
1088217dextran 70 1 MG/ML / hypromellose 3 MG/ML Ophthalmic Solution [Bion Tears]SBD538c2a89-efb5-4132-b678-5a78f23cb7133
309714dextran 70 1 MG/ML / hypromellose 3 MG/ML Ophthalmic SolutionSCD538c2a89-efb5-4132-b678-5a78f23cb7133
1088217Bion Tears (dextran 70 0.1 % / hypromellose 0.3 % ) Ophthalmic SolutionSY538c2a89-efb5-4132-b678-5a78f23cb7133
309714dextran 70 0.1 % / hypromellose 0.3 % Ophthalmic DropsSY538c2a89-efb5-4132-b678-5a78f23cb7133

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0065-9305-010006593050128 VIAL in 1 CARTON (0065-9305-01) / .4 mL in 1 VIAL28 vial2023-04-01NoNoHistorical