Diazepam

Product NDC: 70518-4704
Requested package NDC: 70518-4704-0
11-digit product format: 705184704
Labeler code: 70518
Product ID: 70518-4704_571ff0e0-2d04-bebc-e063-6394a90a8d53
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diazepam
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: REMEDYREPACK INC.
Application: ANDA218450
Marketing category: ANDA
Marketing start: 2026-07-19
Substance: DIAZEPAM
Active strength: 10 mg/2mL
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
A218450-001	DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP		2024-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218450-001	AP

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.

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	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218450-001	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE / INJECTION	AP	2024-04-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218450-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218450-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218450-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218450-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218450-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218450-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218450-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218450-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218450-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218450-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218450-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218450-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218450-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218450-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218450-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218450-001	AP	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218450-001	AP	1	`a50c72e98297…`

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: Diazepam
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIAZEPAM	10 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q3JTX2Q7TU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2120550	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
b4a045e4-d6ce-475d-abe4-590941bd3815	Available on FDA.report

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
Diazepam	DIAZEPAM	REMEDYREPACK INC.	b4a045e4-d6ce-475d-abe4-590941bd3815	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218450 application number: ANDA218450 ndc (package): 70518-4704-0 ndc (product): 70518-4704 ndc11 (package): 70518470400
Diazepam	DIAZEPAM	Sagent Pharmaceuticals	7a912f1a-deee-46df-a8df-22a0afb06529	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218450 application number: ANDA218450
Diazepam	DIAZEPAM	Alembic Pharmaceuticals Inc.	6b6ca65b-4ede-47b9-bbf3-05bb67c0c71d	2024-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218450 application number: ANDA218450
Diazepam	DIAZEPAM	Alembic Pharmaceuticals Limited	1632f040-3b2c-43da-a42f-f2baf5ec778a	2024-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218450 application number: ANDA218450

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-4704-0	70518470400	10 SYRINGE, GLASS in 1 CARTON (70518-4704-0) / 2 mL in 1 SYRINGE, GLASS (70518-4704-1)	2026-07-19	No	No	Current