Midazolam Hydrochloride

Product NDC: 60687-576
Requested package NDC: 60687-576-10
11-digit product format: 606870576
Labeler code: 60687
Product ID: 60687-576_57afebca-8a3d-c511-e063-6394a90a2cb0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Midazolam Hydrochloride
Dosage form: SYRUP
Route: ORAL
Labeler: American Health Packaging
Application: ANDA075873
Marketing category: ANDA
Marketing start: 2021-06-15
Substance: MIDAZOLAM HYDROCHLORIDE
Active strength: 2 mg/mL
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
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 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
A075873-001	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075873-001	AA

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075873-001	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP / ORAL	AA	RS	2002-04-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075873-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075873-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075873-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075873-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075873-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075873-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075873-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075873-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075873-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075873-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075873-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075873-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075873-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075873-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075873-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075873-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075873-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075873-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075873-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075873-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075873-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075873-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075873-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075873-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075873-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075873-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075873-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075873-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075873-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075873-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075873-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075873-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075873-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075873-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075873-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075873-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075873-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075873-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075873-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075873-001	AA	1	`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: Midazolam Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MIDAZOLAM HYDROCHLORIDE	2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W7TTW573JJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
422410	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
fc93242b-0abf-466a-8413-8a365620ee75	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1d526338-43ba-4cef-8730-5a757122f8ce	Product name	1	20260218
8118475d-d61b-4326-b353-56e9cf8c8d9f	Product name	3	20260218
f69f3735-bf62-03e6-cc7a-5af4af89ec8a	Product name	5	20250516
4cc03496-da49-494d-b71d-757fe6737fa2	Product name	1	20230717
06641162-4d53-492d-8ff2-5951a469060f	Product name	1	20230420
46ca420c-e4d5-4e6c-9b2f-cea269a262e8	Product name	1	20230320
b84efe2b-3f4e-4b09-90f9-1d24a61ec30e	Product name	1	20190808
bb7f99f4-8b2b-42a4-8f5a-fcf7dc204f16	Product name	1	20181220
31f18c4e-1938-700a-43de-b9e218c36edc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60687-576-03	Midazolam Hydrochloride	2.5 mL in 1 CUP, UNIT-DOSE	SYRUP	2.5	4
60687-576-04	Midazolam Hydrochloride	10 in 1 TRAY	SYRUP	10	4
60687-576-10	Midazolam Hydrochloride	3 in 1 CASE	SYRUP	3	4
60687-576-40	Midazolam Hydrochloride	5 mL in 1 CUP, UNIT-DOSE	SYRUP	5	4
60687-576-46	Midazolam Hydrochloride	10 in 1 TRAY	SYRUP	10	4
60687-576-86	Midazolam Hydrochloride	3 in 1 CASE	SYRUP	3	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-576-03	ML - Milliliter	60687-576	19b9aac4-b9ad-4025-8426-02a466fcae87	1	2021-06-02
60687-576-04	ML - Milliliter	60687-576	5e70e6f4-498f-4f52-8520-c59b6e0d420e	1	2021-07-15
60687-576-10	ML - Milliliter	60687-576	9c4a46b0-1b7d-493d-9418-d1ca29f7c471	1	2021-06-02
60687-576-40	ML - Milliliter	60687-576	dd2b08e4-5041-431b-9949-5e91514b3809	1	2021-06-02
60687-576-46	ML - Milliliter	60687-576	a6558fa5-5b77-4c0f-8528-d00b1a1cb1aa	1	2021-07-15
60687-576-86	ML - Milliliter	60687-576	c28e926a-e207-4057-9264-80f54b96b4b2	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-576	MIDAZOLAM HYDROCHLORIDE SYRUP [AMERICAN HEALTH PACKAGING]	4	Current NDC, Legacy NDC, 6 package rows	20250514_fc93242b-0abf-466a-8413-8a365620ee75.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	American Health Packaging	fc93242b-0abf-466a-8413-8a365620ee75	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075873 application number: ANDA075873 ndc (package): 60687-576-10 ndc (product): 60687-576 ndc11 (package): 60687057610
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Precision Dose Inc.	9a443652-6aff-4e27-83fe-90c65fa0f3c1	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075873 application number: ANDA075873
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Precision Dose Inc.	557ef7bf-9341-47f9-804d-430a24982fa6	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075873 application number: ANDA075873
Midazolam Hydrochloride	MIDAZOLAM HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	a833c24b-6dca-44d7-a0d6-20012fa1ea77	2025-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075873 application number: ANDA075873

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W7TTW573JJ	MIDAZOLAM HYDROCHLORIDE	59467-96-8	MIDAZOLAM HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
422410	midazolam 10 MG in 5 mL Oral Solution	PSN	fc93242b-0abf-466a-8413-8a365620ee75	4
422410	midazolam 2 MG/ML Oral Solution	SCD	fc93242b-0abf-466a-8413-8a365620ee75	4
422410	midazolam (as midazolam hydrochloride) 10 MG per 5 ML Syrup	SY	fc93242b-0abf-466a-8413-8a365620ee75	4
422410	midazolam (as midazolam hydrochloride) 2 MG/ML Syrup	SY	fc93242b-0abf-466a-8413-8a365620ee75	4
422410	midazolam 10 MG per 5 ML Oral Solution	SY	fc93242b-0abf-466a-8413-8a365620ee75	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-576-10	60687057610	3 TRAY in 1 CASE (60687-576-10) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-576-04) / 2.5 mL in 1 CUP, UNIT-DOSE (60687-576-03)	3 tray	2021-06-15	0000-00-00	No	No	Current