Alprazolam ODT C-IV

Product NDC: 72189-637
11-digit product format: 721890637
Labeler code: 72189
Product ID: 72189-637_4d3aab18-54e7-cb65-e063-6394a90a9b26
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alprazolam ODT C-IV
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Direct_Rx
Application: ANDA078088
Marketing category: ANDA
Marketing start: 2025-08-22
Substance: ALPRAZOLAM
Active strength: .5 mg/1
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078088-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09
A078088-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09
A078088-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09
A078088-004	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A078088-001	AB
A078088-002	AB
A078088-003	AB
A078088-004	AB

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 5 · 172 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	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078088-001	ALPRAZOLAM	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078088-002	ALPRAZOLAM	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078088-003	ALPRAZOLAM	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2009-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078088-004	ALPRAZOLAM	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-01-09	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A078088-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078088-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078088-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078088-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078088-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078088-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078088-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078088-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078088-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078088-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078088-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078088-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078088-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078088-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078088-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078088-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078088-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078088-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078088-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078088-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078088-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078088-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078088-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078088-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078088-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078088-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078088-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078088-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078088-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078088-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078088-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078088-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078088-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078088-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078088-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078088-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078088-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078088-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078088-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078088-004	AB	1	`5bbf6a4d5a75…`

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: Alprazolam ODT C-IV
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALPRAZOLAM	.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YU55MQ3IZY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
485415	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
3cf95203-c8b4-9f06-e063-6394a90abc9c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
2ffbe5ef-58ff-88b9-e291-045e0f861f4f	Product name	4	20180827
1f9e6d58-49d3-d9c1-e570-4bb0466a2c0b	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
a1a11520-f3e2-68fa-8bd9-e80b271ef797	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
d153678e-a3c8-bad8-cfe0-385656dde0e7	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-637-02	Alprazolam ODT C-IV	2 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	2		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-637-02	EA - Each	72189-637	4d51c7b1-9537-4780-8193-238944ff3c5b	1	2025-10-14

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam	ALPRAZOLAM	Par Health USA, LLC	ff1630b4-2044-433c-96bc-0bb4ae8d42a0	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078088 application number: ANDA078088
Alprazolam ODT C-IV	ALPRAZOLAM ODT C-IV	Direct_Rx	3cf95203-c8b4-9f06-e063-6394a90abc9c	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078088 application number: ANDA078088 ndc (product): 72189-637

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YU55MQ3IZY	ALPRAZOLAM	28981-97-7	ALPRAZOLAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
485415	ALPRAZolam 0.5 MG Disintegrating Oral Tablet	PSN	3cf95203-c8b4-9f06-e063-6394a90abc9c	2
485415	alprazolam 0.5 MG Disintegrating Oral Tablet	SCD	3cf95203-c8b4-9f06-e063-6394a90abc9c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-637-02	72189063702	2 TABLET, ORALLY DISINTEGRATING in 1 CARTON (72189-637-02)	2025-08-22	No	No	Current