ZOLYMBUS

Product NDC: 82584-010
11-digit product format: 825840010
Labeler code: 82584
Product ID: 82584-010_4badbaf4-122e-3878-e063-6294a90ab4ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bimatoprost
Dosage form: GEL
Route: OPHTHALMIC
Labeler: Thea Pharma Inc.
Application: NDA217307
Marketing category: NDA
Marketing start: 2026-02-26
Substance: BIMATOPROST
Active strength: .1 mg/g
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217307-001	ZOLYMBUS	BIMATOPROST	0.01%	GEL / OPHTHALMIC		RLD, RS	2025-09-09

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217307-001	10314780	2036-06-08	U-1295	Drug product	2025-10-03

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217307-001	NDF	2028-09-09

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217307-001	ZOLYMBUS	0.01%	GEL / OPHTHALMIC	RLD, RS	2025-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217307-001	ZOLYMBUS	0.01%	GEL / OPHTHALMIC	RLD, RS	2025-09-09	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217307-001	ZOLYMBUS	0.01%	GEL / OPHTHALMIC	RLD, RS	2025-09-09	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217307-001	10314780	2036-06-08	U-1295	Drug product	2025-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217307-001	10314780	2036-06-08	U-1295	Drug product	2025-10-03	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217307-001	10314780	2036-06-08	U-1295	Drug product	2025-10-03	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217307-001	NDF	2028-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217307-001	NDF	2028-09-09	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217307-001	NDF	2028-09-09	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BIMATOPROST	.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
QXS94885MZ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2725168	Internal RxNorm lookup
2725620	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f4504a0c-7998-4084-9e05-f999f1d051ed	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f71952f0-5c3a-ff37-f1fb-fed3868f6302	Product name	8	20260105
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
546f403c-5466-48b9-a79e-80b68d2b77d8	Product name	1	20200706
3471d048-4165-432e-a2dc-905eb43247db	Product name	4	20200611
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82584-010-10	ZOLYMBUS	1 in 1 CARTON	GEL	1	5
82584-010-10	ZOLYMBUS	10 in 1 POUCH	GEL	10	5
82584-010-30	ZOLYMBUS	3 in 1 CARTON	GEL	3	5
82584-010-35	ZOLYMBUS	10 in 1 POUCH	GEL	10	5
82584-010-35	ZOLYMBUS	3 in 1 CARTON	GEL	3	5
82584-010-81	ZOLYMBUS	0.3 g in 1 VIAL, SINGLE-DOSE	GEL	0.3	5
82584-010-81	ZOLYMBUS	10 in 1 POUCH	GEL	10	5

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOLYMBUS	BIMATOPROST	Thea Pharma Inc.	f4504a0c-7998-4084-9e05-f999f1d051ed	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217307 application number: NDA217307 ndc (product): 82584-010

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QXS94885MZ	BIMATOPROST	155206-00-1	BIMATOPROST

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2725168	bimatoprost 0.01 % Ophthalmic Gel	PSN	f4504a0c-7998-4084-9e05-f999f1d051ed	5
2725620	ZOLYMBUS 0.01 % Ophthalmic Gel	PSN	f4504a0c-7998-4084-9e05-f999f1d051ed	5
2725620	bimatoprost 0.0001 MG/MG Ophthalmic Gel [Zolymbus]	SBD	f4504a0c-7998-4084-9e05-f999f1d051ed	5
2725168	bimatoprost 0.0001 MG/MG Ophthalmic Gel	SCD	f4504a0c-7998-4084-9e05-f999f1d051ed	5
2725168	bimatoprost 0.01 % Ophthalmic Gel	SY	f4504a0c-7998-4084-9e05-f999f1d051ed	5
2725620	Zolymbus 0.0001 MG/MG Ophthalmic Gel	SY	f4504a0c-7998-4084-9e05-f999f1d051ed	5
2725620	Zolymbus 0.01 % Ophthalmic Gel	SY	f4504a0c-7998-4084-9e05-f999f1d051ed	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82584-010-10	82584001010	1 POUCH in 1 CARTON (82584-010-10) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .3 g in 1 VIAL, SINGLE-DOSE	1 pouch	2026-02-26	Yes	No	Current
82584-010-30	82584001030	3 POUCH in 1 CARTON (82584-010-30) / 10 VIAL, SINGLE-DOSE in 1 POUCH (82584-010-81) / .3 g in 1 VIAL, SINGLE-DOSE	3 pouch	2026-02-26	No	No	Current
82584-010-35	82584001035	3 POUCH in 1 CARTON (82584-010-35) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .3 g in 1 VIAL, SINGLE-DOSE	3 pouch	2026-02-26	Yes	No	Current
82584-010-81	82584001081	0.3 g in 1 VIAL, SINGLE-DOSE	0.3 g				Historical