MIOSTAT

Product NDC: 0065-0023
11-digit product format: 000650023
Labeler code: 0065
Product ID: 0065-0023_a76a34d0-2e07-408d-a8c8-d00f2715cad7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbachol
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Alcon Laboratories, Inc.
Application: NDA016968
Marketing category: NDA
Marketing start: 1974-04-15
Substance: CARBACHOL
Active strength: .1 mg/mL
Pharmacologic classes: Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [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 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
N016968-001	MIOSTAT	CARBACHOL	0.01%	SOLUTION / INTRAOCULAR		RLD, RS, Approved before 1982

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016968-001	MIOSTAT	0.01%	SOLUTION / INTRAOCULAR	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBACHOL	.1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8Y164V895Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308966	Internal RxNorm lookup
991606	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
f28d7a56-e079-4a8b-ad81-9a97c780de67	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
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
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
76dbb916-cd7f-7147-fbde-e858c08e0e3c	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0065-0023-15	MIOSTAT	1.5 mL in 1 VIAL, GLASS	SOLUTION	1.5		12
0065-0023-15	MIOSTAT	12 in 1 CARTON	SOLUTION	12		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0023-15	ML - Milliliter	0065-0023	5bf22fcb-4cb8-405e-89e8-b687e3b6a35b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBACHOL	ACTIVE INGREDIENT	8Y164V895Y	MIOSTAT (CARBACHOL) SOLUTION [ALCON LABORATORIES, INC.]	3
CARBACHOL	ACTIVE MOIETY	8Y164V895Y	MIOSTAT (CARBACHOL) SOLUTION [ALCON LABORATORIES, INC.]	3
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	MIOSTAT (CARBACHOL) SOLUTION [ALCON LABORATORIES, INC.]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	MIOSTAT (CARBACHOL) SOLUTION [ALCON LABORATORIES, INC.]	3
MAGNESIUM CHLORIDE	INACTIVE INGREDIENT	02F3473H9O	MIOSTAT (CARBACHOL) SOLUTION [ALCON LABORATORIES, INC.]	3
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	MIOSTAT (CARBACHOL) SOLUTION [ALCON LABORATORIES, INC.]	3
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	MIOSTAT (CARBACHOL) SOLUTION [ALCON LABORATORIES, INC.]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	MIOSTAT (CARBACHOL) SOLUTION [ALCON LABORATORIES, INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	MIOSTAT (CARBACHOL) SOLUTION [ALCON LABORATORIES, INC.]	3
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	MIOSTAT (CARBACHOL) SOLUTION [ALCON LABORATORIES, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	MIOSTAT (CARBACHOL) SOLUTION [ALCON LABORATORIES, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-0023	MIOSTAT (CARBACHOL) SOLUTION [ALCON LABORATORIES, INC.]	12	Current NDC, Legacy NDC, 2 package rows	20230211_f28d7a56-e079-4a8b-ad81-9a97c780de67.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
MIOSTAT	CARBACHOL	Alcon Laboratories, Inc.	f28d7a56-e079-4a8b-ad81-9a97c780de67	2023-02-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016968 application number: NDA016968 ndc (product): 0065-0023

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8Y164V895Y	CARBACHOL	51-83-2	CARBACHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308966	carbachol 0.01 % in 1.5 ML Intraocular Injection	PSN	f28d7a56-e079-4a8b-ad81-9a97c780de67	12
991606	MIOSTAT 0.01 % in 1.5 ML Intraocular Injection	PSN	f28d7a56-e079-4a8b-ad81-9a97c780de67	12
991606	1.5 ML carbachol 0.1 MG/ML Injection [Miostat]	SBD	f28d7a56-e079-4a8b-ad81-9a97c780de67	12
308966	1.5 ML carbachol 0.1 MG/ML Injection	SCD	f28d7a56-e079-4a8b-ad81-9a97c780de67	12
991606	1.5 ML Miostat 0.1 MG/ML Injection	SY	f28d7a56-e079-4a8b-ad81-9a97c780de67	12
308966	carbachol 0.01 % per 1.5 ML Intraocular Injection	SY	f28d7a56-e079-4a8b-ad81-9a97c780de67	12
991606	Miostat 0.01 % per 1.5 ML Intraocular Injection	SY	f28d7a56-e079-4a8b-ad81-9a97c780de67	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0065-0023-15	00065002315	12 VIAL, GLASS in 1 CARTON (0065-0023-15) / 1.5 mL in 1 VIAL, GLASS	1974-04-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MIOSTAT™ (CARBACHOL INTRAOCULAR SOLUTION, USP) 0.01%	Alcon Laboratories, Inc. \| Alcon Research LLC \| Siegfried AG	2023-02-10	HUMAN PRESCRIPTION DRUG LABEL	12