Diazepam

Product NDC: 71335-2196
11-digit product format: 713352196
Labeler code: 71335
Product ID: 71335-2196_0b9eb4b8-df02-4899-802b-b03d82ac819c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diazepam
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA071136
Marketing category: ANDA
Marketing start: 2019-10-31
Marketing end: 0000-00-00
Substance: DIAZEPAM
Active strength: 10 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-2196		D	Discontinued by firm	2026-10-05
excluded package	package	71335-2196	71335-2196-0	D	Discontinued by firm	2026-10-05
excluded package	package	71335-2196	71335-2196-1	D	Discontinued by firm	2026-10-05
excluded package	package	71335-2196	71335-2196-2	D	Discontinued by firm	2026-10-05
excluded package	package	71335-2196	71335-2196-3	D	Discontinued by firm	2026-10-05
excluded package	package	71335-2196	71335-2196-4	D	Discontinued by firm	2026-10-05
excluded package	package	71335-2196	71335-2196-5	D	Discontinued by firm	2026-10-05
excluded package	package	71335-2196	71335-2196-6	D	Discontinued by firm	2026-10-05
excluded package	package	71335-2196	71335-2196-7	D	Discontinued by firm	2026-10-05
excluded package	package	71335-2196	71335-2196-8	D	Discontinued by firm	2026-10-05
excluded package	package	71335-2196	71335-2196-9	D	Discontinued by firm	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 1 · 22 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	71335-2196-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-2196-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-2196-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-2196-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-2196-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-2196-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-2196-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-2196-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-2196-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-2196-7	`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	71335-2196-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-2196-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-2196-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-2196-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-2196-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-2196-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-2196-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-2196-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-2196-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-2196-7	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A071136-001	DIAZEPAM	DIAZEPAM	10MG	TABLET / ORAL	AB		1987-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071136-001	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 2 · 43 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	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071136-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1987-02-03	`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	A071136-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071136-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071136-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071136-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071136-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071136-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071136-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071136-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071136-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071136-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071136-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071136-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071136-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071136-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071136-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071136-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071136-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071136-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071136-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071136-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071136-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071136-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071136-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071136-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071136-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071136-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071136-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071136-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071136-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071136-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071136-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071136-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071136-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071136-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071136-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071136-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071136-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071136-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071136-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071136-001	AB	1	`f41ea6bd6efb…`

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
69057c52-36b0-21c0-02d6-d697be15c03c	Product name	4	20260305
da74e203-d183-4c62-8511-c3ef56b5964e	Product name	1	20250213
2792dd44-ff30-4712-8b05-1850c2b4d307	Product name	3	20250211
2fd3ebb9-86c1-64e3-e9b6-3c2ba01c6876	Product name	2	20250102
0f898f8b-23f1-b816-6bfe-c7f8aac7e42b	Product name	2	20240529
2c487d7e-cbfc-4699-9c83-5c1c7521cde9	Product name	1	20200610
02ac201d-7ee6-00c9-f963-81bb5a506b68	Product name	3	20160816

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-2196-0	Diazepam	56 in 1 BOTTLE, PLASTIC	TABLET	56	102
71335-2196-1	Diazepam	20 in 1 BOTTLE, PLASTIC	TABLET	20	102
71335-2196-2	Diazepam	30 in 1 BOTTLE, PLASTIC	TABLET	30	102
71335-2196-3	Diazepam	40 in 1 BOTTLE, PLASTIC	TABLET	40	102
71335-2196-4	Diazepam	50 in 1 BOTTLE, PLASTIC	TABLET	50	102
71335-2196-5	Diazepam	60 in 1 BOTTLE, PLASTIC	TABLET	60	102
71335-2196-6	Diazepam	90 in 1 BOTTLE, PLASTIC	TABLET	90	102
71335-2196-7	Diazepam	100 in 1 BOTTLE, PLASTIC	TABLET	100	102
71335-2196-8	Diazepam	10 in 1 BOTTLE, PLASTIC	TABLET	10	102
71335-2196-9	Diazepam	120 in 1 BOTTLE, PLASTIC	TABLET	120	102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-2196-2	EA - Each	71335-2196	7cc4e60b-9507-47f2-a515-cc30fc4f57b1	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2196	DIAZEPAM TABLET [BRYANT RANCH PREPACK]	102	Legacy NDC, 10 package rows	20240420_7d76cfb9-2e00-4a48-ac88-ae4b7d1132e4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q3JTX2Q7TU	DIAZEPAM	439-14-5	DIAZEPAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197589	diazePAM 10 MG Oral Tablet	PSN	7d76cfb9-2e00-4a48-ac88-ae4b7d1132e4	102
197589	diazepam 10 MG Oral Tablet	SCD	7d76cfb9-2e00-4a48-ac88-ae4b7d1132e4	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-2196-0	71335219600	56 TABLET in 1 BOTTLE, PLASTIC (71335-2196-0)	56 tablet	2022-12-05	0000-00-00	No	No	Current
71335-2196-1	71335219601	20 TABLET in 1 BOTTLE, PLASTIC (71335-2196-1)	20 tablet	2022-12-05	0000-00-00	No	No	Current
71335-2196-2	71335219602	30 TABLET in 1 BOTTLE, PLASTIC (71335-2196-2)	30 tablet	2022-12-05	0000-00-00	No	No	Current
71335-2196-3	71335219603	40 TABLET in 1 BOTTLE, PLASTIC (71335-2196-3)	40 tablet	2022-12-05	0000-00-00	No	No	Current
71335-2196-4	71335219604	50 TABLET in 1 BOTTLE, PLASTIC (71335-2196-4)	50 tablet	2022-12-05	0000-00-00	No	No	Current
71335-2196-5	71335219605	60 TABLET in 1 BOTTLE, PLASTIC (71335-2196-5)	60 tablet	2022-12-05	0000-00-00	No	No	Current
71335-2196-6	71335219606	90 TABLET in 1 BOTTLE, PLASTIC (71335-2196-6)	90 tablet	2022-12-05	0000-00-00	No	No	Current
71335-2196-7	71335219607	100 TABLET in 1 BOTTLE, PLASTIC (71335-2196-7)	100 tablet	2022-12-05	0000-00-00	No	No	Current
71335-2196-8	71335219608	10 TABLET in 1 BOTTLE, PLASTIC (71335-2196-8)	10 tablet	2022-12-05	0000-00-00	No	No	Current
71335-2196-9	71335219609	120 TABLET in 1 BOTTLE, PLASTIC (71335-2196-9)	120 tablet	2022-12-05	0000-00-00	No	No	Current