Alprazolam

Product NDC: 67544-629
11-digit product format: 675440629
Labeler code: 67544
Product ID: 67544-629_02a9e5f5-eeaf-49fa-b28d-1b1f560ea902
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alprazolam
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA074112
Marketing category: ANDA
Marketing start: 1995-12-29
Marketing end: 0000-00-00
Substance: ALPRAZOLAM
Active strength: 1 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 13 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67544-629		I	Inactivated by FDA	2026-10-05
excluded package	package	67544-629	67544-629-15	I	Inactivated by FDA	2026-10-05
excluded package	package	67544-629	67544-629-20	I	Inactivated by FDA	2026-10-05
excluded package	package	67544-629	67544-629-30	I	Inactivated by FDA	2026-10-05
excluded package	package	67544-629	67544-629-45	I	Inactivated by FDA	2026-10-05
excluded package	package	67544-629	67544-629-53	I	Inactivated by FDA	2026-10-05
excluded package	package	67544-629	67544-629-55	I	Inactivated by FDA	2026-10-05
excluded package	package	67544-629	67544-629-60	I	Inactivated by FDA	2026-10-05
excluded package	package	67544-629	67544-629-70	I	Inactivated by FDA	2026-10-05
excluded package	package	67544-629	67544-629-75	I	Inactivated by FDA	2026-10-05
excluded package	package	67544-629	67544-629-80	I	Inactivated by FDA	2026-10-05
excluded package	package	67544-629	67544-629-90	I	Inactivated by FDA	2026-10-05
excluded package	package	67544-629	67544-629-92	I	Inactivated by FDA	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 5 · 273 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-629-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-629-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-629-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-629-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-629-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-629-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-629-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-629-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-629-75	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-629-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-629-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-629-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-629-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-629-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-629-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-629-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-629-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-629-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-629-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-629-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-629-75	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-629-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-629-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-629-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-629-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-629-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-629-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-629-92	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-629-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-629-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-629-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-629-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-629-75	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-629-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-629-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-629-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-629-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-629-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-629-70	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-629-92	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-629-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-629-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-629-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-629-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-629-75	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-629-55	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-629-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-629-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-629-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-629-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-629-70	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-629-92	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-629-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-629-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-629-20	`cfe11265f3b6…`	`090c488252e2…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A074112-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29
A074112-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29
A074112-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A074112-001	AB
A074112-002	AB
A074112-003	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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1995-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1995-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074112-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1995-12-29	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A074112-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074112-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074112-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074112-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074112-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074112-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074112-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074112-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074112-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074112-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074112-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074112-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074112-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074112-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074112-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074112-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074112-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074112-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074112-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074112-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074112-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074112-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074112-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074112-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2ffbe5ef-58ff-88b9-e291-045e0f861f4f	Product name	4	20180827
1f9e6d58-49d3-d9c1-e570-4bb0466a2c0b	Product name	1	20140508
a1a11520-f3e2-68fa-8bd9-e80b271ef797	Product name	1	20140508
d153678e-a3c8-bad8-cfe0-385656dde0e7	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
67544-629-15	Alprazolam Tablets, USP
67544-629-20	Alprazolam Tablets, USP
67544-629-30	Alprazolam Tablets, USP
67544-629-45	Alprazolam Tablets, USP
67544-629-53	Alprazolam Tablets, USP
67544-629-55	Alprazolam Tablets, USP
67544-629-60	Alprazolam Tablets, USP
67544-629-70	Alprazolam Tablets, USP
67544-629-75	Alprazolam Tablets, USP
67544-629-80	Alprazolam Tablets, USP
67544-629-90	Alprazolam Tablets, USP
67544-629-92	Alprazolam Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67544-629-15	Alprazolam	15 in 1 BOTTLE, PLASTIC	TABLET	15	2
67544-629-20	Alprazolam	20 in 1 BOTTLE, PLASTIC	TABLET	20	2
67544-629-30	Alprazolam	30 in 1 BOTTLE, PLASTIC	TABLET	30	2
67544-629-45	Alprazolam	45 in 1 BOTTLE, PLASTIC	TABLET	45	2
67544-629-53	Alprazolam	60 in 1 BOTTLE, PLASTIC	TABLET	60	2
67544-629-55	Alprazolam	75 in 1 BOTTLE, PLASTIC	TABLET	75	2
67544-629-60	Alprazolam	90 in 1 BOTTLE, PLASTIC	TABLET	90	2
67544-629-70	Alprazolam	120 in 1 BOTTLE, PLASTIC	TABLET	120	2
67544-629-75	Alprazolam	150 in 1 BOTTLE, PLASTIC	TABLET	150	2
67544-629-80	Alprazolam	180 in 1 BOTTLE, PLASTIC	TABLET	180	2
67544-629-90	Alprazolam	240 in 1 BOTTLE, PLASTIC	TABLET	240	2
67544-629-92	Alprazolam	270 in 1 BOTTLE, PLASTIC	TABLET	270	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-629-15	EA - Each	67544-629	22e17d52-87fd-4bc3-a46a-c7f64835a66e	1	2013-02-13
67544-629-20	EA - Each	67544-629	30dd25eb-0ad7-4831-95e8-0821c2844191	1	2013-02-13
67544-629-30	EA - Each	67544-629	67ed050e-dcf1-41e7-be53-866de87075fb	1	2013-02-13
67544-629-45	EA - Each	67544-629	2b9cd182-3dd5-45dd-a325-27a55713c74f	1	2013-02-13
67544-629-53	EA - Each	67544-629	9d50f6a8-28d0-4d3a-8cc9-e2d6ffbc78d6	1	2013-02-13
67544-629-55	EA - Each	67544-629	6c4a5f4e-81e7-4a73-bf3d-d6411e198a13	1	2013-02-13
67544-629-60	EA - Each	67544-629	cdbd5a8c-cd5c-41b9-ad12-69d1c6ec36a8	1	2013-02-13
67544-629-70	EA - Each	67544-629	279e15e0-3a4c-4a30-91ce-483a7070f6d1	1	2013-02-13
67544-629-75	EA - Each	67544-629	b2ccc216-2b7f-45d7-be2d-3a813d80fbba	1	2013-02-13
67544-629-80	EA - Each	67544-629	bbb1519c-1812-4464-be59-92ef9ccceb6b	1	2013-02-13
67544-629-90	EA - Each	67544-629	9a9a2be6-a69a-4450-9041-e04bb627f6fe	1	2013-02-13
67544-629-92	EA - Each	67544-629	8d587904-1a35-4b50-bc05-b501639a7b98	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67544-629	ALPRAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 12 package rows	20140422_5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b7.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam	ALPRAZOLAM	REMEDYREPACK INC.	563e09db-2f3d-4ce8-b356-ae44477be6d0	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	A-S Medication Solutions	3c0cb60f-1c3a-48a6-ad16-f14351548412	2025-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	0ffcdbab-17e4-4395-8155-5b6ad00be6c2	2025-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Advanced Rx of Tennessee, LLC	f667458d-ddda-4e9e-e053-2995a90adb5a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Advanced Rx Pharmacy of Tennessee, LLC	b39e2bc8-b691-0f4e-e053-2995a90a00fd	2024-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Sandoz Inc	d9b0e228-17cf-40d7-b62e-5050311c571c	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	f95f4030-e8e0-416f-951d-c4dac09f386a	2023-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	54c790c5-2e6c-439d-8e3b-7502c962a596	2023-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Proficient Rx LP	717ce509-f92e-4ec1-a3c6-aeae54d56f4d	2020-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112
Alprazolam	ALPRAZOLAM	Proficient Rx LP	447efe78-3696-481c-bbae-23199a39ec94	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074112 application number: ANDA074112

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
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b7	2
308048	ALPRAZolam 0.5 MG Oral Tablet	PSN	5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b7	2
197321	ALPRAZolam 1 MG Oral Tablet	PSN	5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b7	2
308047	alprazolam 0.25 MG Oral Tablet	SCD	5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b7	2
308048	alprazolam 0.5 MG Oral Tablet	SCD	5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b7	2
197321	alprazolam 1 MG Oral Tablet	SCD	5fa2dc50-3589-49f7-8fcc-0f7c0e91b3b7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67544-629-15	67544062915	15 in 1 BOTTLE, PLASTIC	Historical
67544-629-20	67544062920	20 in 1 BOTTLE, PLASTIC	Historical
67544-629-30	67544062930	30 in 1 BOTTLE, PLASTIC	Historical
67544-629-45	67544062945	45 in 1 BOTTLE, PLASTIC	Historical
67544-629-53	67544062953	60 in 1 BOTTLE, PLASTIC	Historical
67544-629-55	67544062955	75 in 1 BOTTLE, PLASTIC	Historical
67544-629-60	67544062960	90 in 1 BOTTLE, PLASTIC	Historical
67544-629-70	67544062970	120 in 1 BOTTLE, PLASTIC	Historical
67544-629-75	67544062975	150 in 1 BOTTLE, PLASTIC	Historical
67544-629-80	67544062980	180 in 1 BOTTLE, PLASTIC	Historical
67544-629-90	67544062990	240 in 1 BOTTLE, PLASTIC	Historical
67544-629-92	67544062992	270 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alprazolam Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2014-04-16	HUMAN PRESCRIPTION DRUG LABEL	2