Carteolol Hydrochloride

Product NDC: 61314-238
Requested package NDC: 61314-238-15
11-digit product format: 613140238
Labeler code: 61314
Product ID: 61314-238_c89793f0-318b-4481-8fc0-e9cb0dcc5244
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carteolol Hydrochloride
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Sandoz Inc
Application: ANDA075476
Marketing category: ANDA
Marketing start: 2000-01-05
Substance: CARTEOLOL HYDROCHLORIDE
Active strength: 10 mg/mL
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
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 43.

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
A075476-001	CARTEOLOL HYDROCHLORIDE	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC		RS	2000-01-03

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075476-001	CARTEOLOL HYDROCHLORIDE	1%	SOLUTION/DROPS / OPHTHALMIC	RS	2000-01-03	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Carteolol Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARTEOLOL HYDROCHLORIDE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4797W6I0T4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
978573	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
571fe550-399d-4296-835c-37aa1ab9b409	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a1850243-4250-1591-ccf6-1a6481ef7e2f	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61314-238-05	Carteolol Hydrochloride	5 mL in 1 BOTTLE, PLASTIC	SOLUTION	5	6
61314-238-10	Carteolol Hydrochloride	10 mL in 1 BOTTLE, PLASTIC	SOLUTION	10	6
61314-238-15	Carteolol Hydrochloride	15 mL in 1 BOTTLE, PLASTIC	SOLUTION	15	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61314-238-05	ML - Milliliter	61314-238	25ae6dcd-3159-491d-b857-2901c0394963	1	2012-07-24
61314-238-10	ML - Milliliter	61314-238	859be098-b435-4ec5-b5fd-f4112ca4b64c	1	2012-07-24
61314-238-15	ML - Milliliter	61314-238	22fce40d-fa9d-45f2-aa29-afba1d7d9866	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARTEOLOL HYDROCHLORIDE	ACTIVE INGREDIENT	4797W6I0T4	CARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]	3
CARTEOLOL	ACTIVE MOIETY	8NF31401XG	CARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	CARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]	3
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	CARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]	3
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	CARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	CARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61314-238	CARTEOLOL HYDROCHLORIDE SOLUTION [SANDOZ INC]	6	Current NDC, Legacy NDC, 3 package rows	20220217_571fe550-399d-4296-835c-37aa1ab9b409.zip

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
Carteolol Hydrochloride	CARTEOLOL HYDROCHLORIDE	Sandoz Inc	571fe550-399d-4296-835c-37aa1ab9b409	2021-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075476 application number: ANDA075476 ndc (package): 61314-238-15 ndc (product): 61314-238 ndc11 (package): 61314023815

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4797W6I0T4	CARTEOLOL HYDROCHLORIDE	51781-21-6	CARTEOLOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
978573	carteolol HCl 1 % Ophthalmic Solution	PSN	571fe550-399d-4296-835c-37aa1ab9b409	6
978573	carteolol hydrochloride 10 MG/ML Ophthalmic Solution	SCD	571fe550-399d-4296-835c-37aa1ab9b409	6
978573	carteolol hydrochloride 1 % Ophthalmic Solution	SY	571fe550-399d-4296-835c-37aa1ab9b409	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61314-238-15	61314023815	15 mL in 1 BOTTLE, PLASTIC (61314-238-15)	15 ml	2000-01-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carteolol Hydrochloride Ophthalmic Solution USP, 1% Rx Only Sterile	Sandoz Inc	2021-08-31	HUMAN PRESCRIPTION DRUG LABEL	6