FDA.reportPublic FDA data

Bimatoprost

Product NDC
70756-628
11-digit product format
707560628
Labeler code
70756
Product ID
70756-628_4ba103dc-872b-49f0-ae33-f1fc4b98c776
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bimatoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Lifestar Pharma LLC
Application
ANDA218196
Marketing category
ANDA
Marketing start
2026-03-17
Substance
BIMATOPROST
Active strength
.1 mg/mL
Pharmacologic classes
Prostaglandin Analog [EPC], Prostaglandins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A218196-001BIMATOPROSTBIMATOPROST0.01%SOLUTION/DROPS / OPHTHALMICAB2025-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218196-001AB

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 UTC2026-02A218196-001BIMATOPROST0.01%SOLUTION/DROPS / OPHTHALMICAB2025-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218196-001BIMATOPROST0.01%SOLUTION/DROPS / OPHTHALMICAB2025-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A218196-001BIMATOPROST0.01%SOLUTION/DROPS / OPHTHALMICAB2025-03-176a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218196-001BIMATOPROST0.01%SOLUTION/DROPS / OPHTHALMICAB2025-03-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218196-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218196-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218196-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218196-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Bimatoprost
Listing expiration
2027-12-31

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
6ff31e11-fa48-4bfe-958c-47fedf21ce3dAvailable 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
70756-628-30Bimatoprost7.5 mL in 1 BOTTLESOLUTION/ DROPS7.54
70756-628-30Bimatoprost1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-628-30ML - Milliliter70756-62881da2cc1-9766-4c8a-baa7-8306de0c9ce912026-04-20

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BimatoprostBIMATOPROSTFirst Nation Group, LLC6a74ad65-dd76-45c1-9bbe-4218a9978b702026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218196
application number: ANDA218196
BimatoprostBIMATOPROSTLifestar Pharma LLC6ff31e11-fa48-4bfe-958c-47fedf21ce3d2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218196
application number: ANDA218196
ndc (product): 70756-628

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1009339bimatoprost 0.01 % Ophthalmic SolutionPSN6ff31e11-fa48-4bfe-958c-47fedf21ce3d4
1009339bimatoprost 0.1 MG/ML Ophthalmic SolutionSCD6ff31e11-fa48-4bfe-958c-47fedf21ce3d4
1009339bimatoprost 0.01 % Ophthalmic SolutionSY6ff31e11-fa48-4bfe-958c-47fedf21ce3d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-628-30707560628301 BOTTLE in 1 CARTON (70756-628-30) / 7.5 mL in 1 BOTTLE1 bottle2026-03-17NoNoCurrent