FDA.reportPublic FDA data

Bimatoprost

Product NDC
60219-2149
11-digit product format
602192149
Labeler code
60219
Product ID
60219-2149_34ba1345-2347-448c-8c94-b8b93404ade6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bimatoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA217289
Marketing category
ANDA
Marketing start
2025-09-22
Substance
BIMATOPROST
Active strength
.1 mg/mL
Pharmacologic classes
Prostaglandin Analog [EPC], Prostaglandins [CS]
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
A217289-001BIMATOPROSTBIMATOPROST0.01%SOLUTION/DROPS / OPHTHALMICAB2025-09-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217289-001AB

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 UTC2026-02A217289-001BIMATOPROST0.01%SOLUTION/DROPS / OPHTHALMICAB2025-09-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217289-001BIMATOPROST0.01%SOLUTION/DROPS / OPHTHALMICAB2025-09-2231067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217289-001BIMATOPROST0.01%SOLUTION/DROPS / OPHTHALMICAB2025-09-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217289-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217289-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217289-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIMATOPROST.1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QXS94885MZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1009339Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea563519-3eae-4ac7-8234-173b0bd9a4f6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f71952f0-5c3a-ff37-f1fb-fed3868f6302Product name820260105
546f403c-5466-48b9-a79e-80b68d2b77d8Product name120200706
3471d048-4165-432e-a2dc-905eb43247dbProduct name420200611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-2149-1Bimatoprost2.5 mL in 1 BOTTLESOLUTION/ DROPS2.54
60219-2149-1Bimatoprost1 in 1 CARTONSOLUTION/ DROPS14
60219-2149-2Bimatoprost7.5 mL in 1 BOTTLESOLUTION/ DROPS7.54
60219-2149-2Bimatoprost1 in 1 CARTONSOLUTION/ DROPS14
60219-2149-4Bimatoprost5 mL in 1 BOTTLESOLUTION/ DROPS54
60219-2149-4Bimatoprost1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-2149-1ML - Milliliter60219-2149044c816b-8a94-4d40-9f07-116532cdfc0f12026-04-20
60219-2149-2ML - Milliliter60219-2149a115007b-c038-4572-a7a9-f57f8546240e12026-04-20
60219-2149-4ML - Milliliter60219-21491afbd3a2-4446-4014-8d9e-0fbcdb85e5ff12026-04-20

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BimatoprostBIMATOPROSTAmneal Pharmaceuticals NY LLCea563519-3eae-4ac7-8234-173b0bd9a4f62025-05-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217289
application number: ANDA217289
ndc (product): 60219-2149

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1009339bimatoprost 0.01 % Ophthalmic SolutionPSNea563519-3eae-4ac7-8234-173b0bd9a4f64
1009339bimatoprost 0.1 MG/ML Ophthalmic SolutionSCDea563519-3eae-4ac7-8234-173b0bd9a4f64
1009339bimatoprost 0.01 % Ophthalmic SolutionSYea563519-3eae-4ac7-8234-173b0bd9a4f64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60219-2149-1602192149011 BOTTLE in 1 CARTON (60219-2149-1) / 2.5 mL in 1 BOTTLE1 bottle2025-09-22NoNoCurrent
60219-2149-2602192149021 BOTTLE in 1 CARTON (60219-2149-2) / 7.5 mL in 1 BOTTLE1 bottle2025-09-22NoNoCurrent
60219-2149-4602192149041 BOTTLE in 1 CARTON (60219-2149-4) / 5 mL in 1 BOTTLE1 bottle2025-09-22NoNoCurrent