Diazepam

Product NDC: 0172-3927
11-digit product format: 001723927
Labeler code: 0172
Product ID: 0172-3927_db225e5f-9265-4460-ab58-3305246c6258
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diazepam
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA071322
Marketing category: ANDA
Marketing start: 1986-12-10
Substance: DIAZEPAM
Active strength: 10 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A071322-001	DIAZEPAM	DIAZEPAM	10MG	TABLET / ORAL	AB		1986-12-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071322-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071322-001	DIAZEPAM	10MG	TABLET / ORAL	AB	1986-12-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071322-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071322-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071322-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071322-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071322-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071322-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071322-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071322-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071322-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071322-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071322-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071322-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071322-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071322-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071322-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071322-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071322-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071322-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071322-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071322-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071322-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071322-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071322-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071322-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071322-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071322-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071322-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071322-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071322-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071322-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071322-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071322-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071322-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071322-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071322-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071322-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071322-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071322-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071322-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071322-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diazepam
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIAZEPAM	10 mg/1

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197589	Internal RxNorm lookup
197590	Internal RxNorm lookup
197591	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
48aa32cb-047a-414a-822e-82a5f26d8817	Available on FDA.report

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
0172-3927-60	Diazepam	100 in 1 BOTTLE	TABLET	100	17
0172-3927-70	Diazepam	500 in 1 BOTTLE	TABLET	500	17
0172-3927-80	Diazepam	1000 in 1 BOTTLE	TABLET	1000	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0172-3927-60	EA - Each	0172-3927	d540a907-1211-424a-a6f8-f3b4956b1436	1	2012-07-24
0172-3927-70	EA - Each	0172-3927	a2e4c4a6-132d-4508-bf06-170356610ebb	1	2012-07-24
0172-3927-80	EA - Each	0172-3927	3bad48ea-9c90-49b2-af77-40fe43d0e111	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [IVAX PHARMACEUTICALS, INC.]	10
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [IVAX PHARMACEUTICALS, INC.]	10
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DIAZEPAM TABLET [IVAX PHARMACEUTICALS, INC.]	10
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DIAZEPAM TABLET [IVAX PHARMACEUTICALS, INC.]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [IVAX PHARMACEUTICALS, INC.]	10
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIAZEPAM TABLET [IVAX PHARMACEUTICALS, INC.]	10
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIAZEPAM TABLET [IVAX PHARMACEUTICALS, INC.]	10
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DIAZEPAM TABLET [IVAX PHARMACEUTICALS, INC.]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIAZEPAM TABLET [IVAX PHARMACEUTICALS, INC.]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [IVAX PHARMACEUTICALS, INC.]	10
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DIAZEPAM TABLET [IVAX PHARMACEUTICALS, INC.]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIAZEPAM TABLET [IVAX PHARMACEUTICALS, INC.]	10
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	6
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	6
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	6
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	6
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DIAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DIAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DIAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC.]	6
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]	2
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]	2
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [DIRECT RX]	1
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [PROFICIENT RX LP]	1
DIAZEPAM	ACTIVE INGREDIENT	Q3JTX2Q7TU	DIAZEPAM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [DIRECT RX]	1
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [PROFICIENT RX LP]	1
DIAZEPAM	ACTIVE MOIETY	Q3JTX2Q7TU	DIAZEPAM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DIAZEPAM TABLET [PROFICIENT RX LP]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DIAZEPAM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DIAZEPAM TABLET [PROFICIENT RX LP]	1
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	DIAZEPAM TABLET [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIAZEPAM TABLET [DIRECT RX]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIAZEPAM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIAZEPAM TABLET [PROFICIENT RX LP]	1
GALACTOSE MONOHYDRATE	INACTIVE INGREDIENT	2C22T7DYYR	DIAZEPAM TABLET [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIAZEPAM TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIAZEPAM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIAZEPAM TABLET [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIAZEPAM TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DIAZEPAM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DIAZEPAM TABLET [PROFICIENT RX LP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIAZEPAM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIAZEPAM TABLET [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0172-3927	DIAZEPAM TABLET [TEVA PHARMACEUTICALS USA, INC.]	17	Current NDC, Legacy NDC, 3 package rows	20240222_48aa32cb-047a-414a-822e-82a5f26d8817.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diazepam	DIAZEPAM	REMEDYREPACK INC.	5ebef149-1858-4199-aaed-7b9341fae63d	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	Coupler LLC	5111654f-a026-71b2-e063-6294a90ab49b	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	REMEDYREPACK INC.	d7a4b3c7-7021-4764-8c21-49e4bc6f6058	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
DIAZEPAM	DIAZEPAM	Direct_Rx	4b0c9c0a-4274-4d56-a7a4-bc497916469c	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	PD-Rx Pharmaceuticals, Inc.	84cecab3-d0e6-436b-996b-0b598e972308	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	A-S Medication Solutions	b47dc708-e83b-4224-bdb5-c9b7abd35cfb	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	Asclemed USA, Inc.	32e7bfa1-6060-4041-a0e5-249cacb84ebc	2025-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	Advanced Rx Pharmacy of Tennessee, LLC	b7002d26-3856-4c2f-e053-2995a90aea60	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	NuCare Pharmaceuticals,Inc.	859461ea-5861-8185-e053-2991aa0a954a	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	Bryant Ranch Prepack	078bbb41-7e3a-48db-87f0-ec6a6ec0194e	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	Teva Pharmaceuticals USA, Inc.	48aa32cb-047a-414a-822e-82a5f26d8817	2024-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322 ndc (product): 0172-3927
Diazepam	DIAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	9cf031ae-d59b-430d-9b15-415ae2e49c98	2022-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322
Diazepam	DIAZEPAM	Proficient Rx LP	f8d26f65-a015-4bfc-b1fa-8595d72af48c	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071322 application number: ANDA071322

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	b47dc708-e83b-4224-bdb5-c9b7abd35cfb	34
197591	diazePAM 5 MG Oral Tablet	PSN	b47dc708-e83b-4224-bdb5-c9b7abd35cfb	34
197589	diazepam 10 MG Oral Tablet	SCD	b47dc708-e83b-4224-bdb5-c9b7abd35cfb	34
197591	diazepam 5 MG Oral Tablet	SCD	b47dc708-e83b-4224-bdb5-c9b7abd35cfb	34
197589	diazePAM 10 MG Oral Tablet	PSN	84cecab3-d0e6-436b-996b-0b598e972308	24
197589	diazePAM 10 MG Oral Tablet	PSN	5ebef149-1858-4199-aaed-7b9341fae63d	24
197589	diazepam 10 MG Oral Tablet	SCD	84cecab3-d0e6-436b-996b-0b598e972308	24
197589	diazepam 10 MG Oral Tablet	SCD	5ebef149-1858-4199-aaed-7b9341fae63d	24
197589	diazePAM 10 MG Oral Tablet	PSN	0bfdf83c-6ae3-09e9-e054-00144ff88e88	22
197589	diazepam 10 MG Oral Tablet	SCD	0bfdf83c-6ae3-09e9-e054-00144ff88e88	22
197589	diazePAM 10 MG Oral Tablet	PSN	d7a4b3c7-7021-4764-8c21-49e4bc6f6058	21
197589	diazepam 10 MG Oral Tablet	SCD	d7a4b3c7-7021-4764-8c21-49e4bc6f6058	21
197589	diazePAM 10 MG Oral Tablet	PSN	4b0c9c0a-4274-4d56-a7a4-bc497916469c	18
197591	diazePAM 5 MG Oral Tablet	PSN	4b0c9c0a-4274-4d56-a7a4-bc497916469c	18
197589	diazepam 10 MG Oral Tablet	SCD	4b0c9c0a-4274-4d56-a7a4-bc497916469c	18
197591	diazepam 5 MG Oral Tablet	SCD	4b0c9c0a-4274-4d56-a7a4-bc497916469c	18
197589	diazePAM 10 MG Oral Tablet	PSN	48aa32cb-047a-414a-822e-82a5f26d8817	17
197590	diazePAM 2 MG Oral Tablet	PSN	48aa32cb-047a-414a-822e-82a5f26d8817	17
197591	diazePAM 5 MG Oral Tablet	PSN	48aa32cb-047a-414a-822e-82a5f26d8817	17
197589	diazepam 10 MG Oral Tablet	SCD	48aa32cb-047a-414a-822e-82a5f26d8817	17
197590	diazepam 2 MG Oral Tablet	SCD	48aa32cb-047a-414a-822e-82a5f26d8817	17
197591	diazepam 5 MG Oral Tablet	SCD	48aa32cb-047a-414a-822e-82a5f26d8817	17
197589	diazePAM 10 MG Oral Tablet	PSN	078bbb41-7e3a-48db-87f0-ec6a6ec0194e	12
197589	diazepam 10 MG Oral Tablet	SCD	078bbb41-7e3a-48db-87f0-ec6a6ec0194e	12
197589	diazePAM 10 MG Oral Tablet	PSN	1995880f-e2f3-4eda-b7ff-b28141d38185	6
197589	diazePAM 10 MG Oral Tablet	PSN	9cf031ae-d59b-430d-9b15-415ae2e49c98	6
197589	diazePAM 10 MG Oral Tablet	PSN	b7002d26-3856-4c2f-e053-2995a90aea60	6
197589	diazePAM 10 MG Oral Tablet	PSN	bc6b93b1-4612-4b6a-8c25-53a17cd494af	6
197590	diazePAM 2 MG Oral Tablet	PSN	1995880f-e2f3-4eda-b7ff-b28141d38185	6
197591	diazePAM 5 MG Oral Tablet	PSN	bc6b93b1-4612-4b6a-8c25-53a17cd494af	6
197591	diazePAM 5 MG Oral Tablet	PSN	1995880f-e2f3-4eda-b7ff-b28141d38185	6
197589	diazepam 10 MG Oral Tablet	SCD	b7002d26-3856-4c2f-e053-2995a90aea60	6
197589	diazepam 10 MG Oral Tablet	SCD	bc6b93b1-4612-4b6a-8c25-53a17cd494af	6
197589	diazepam 10 MG Oral Tablet	SCD	1995880f-e2f3-4eda-b7ff-b28141d38185	6
197589	diazepam 10 MG Oral Tablet	SCD	9cf031ae-d59b-430d-9b15-415ae2e49c98	6
197590	diazepam 2 MG Oral Tablet	SCD	1995880f-e2f3-4eda-b7ff-b28141d38185	6
197591	diazepam 5 MG Oral Tablet	SCD	1995880f-e2f3-4eda-b7ff-b28141d38185	6
197591	diazepam 5 MG Oral Tablet	SCD	bc6b93b1-4612-4b6a-8c25-53a17cd494af	6
197589	diazePAM 10 MG Oral Tablet	PSN	f8d26f65-a015-4bfc-b1fa-8595d72af48c	4
197589	diazepam 10 MG Oral Tablet	SCD	f8d26f65-a015-4bfc-b1fa-8595d72af48c	4
197589	diazePAM 10 MG Oral Tablet	PSN	859461ea-5861-8185-e053-2991aa0a954a	3
197589	diazePAM 10 MG Oral Tablet	PSN	32e7bfa1-6060-4041-a0e5-249cacb84ebc	3
197590	diazePAM 2 MG Oral Tablet	PSN	32e7bfa1-6060-4041-a0e5-249cacb84ebc	3
197591	diazePAM 5 MG Oral Tablet	PSN	32e7bfa1-6060-4041-a0e5-249cacb84ebc	3
197589	diazepam 10 MG Oral Tablet	SCD	859461ea-5861-8185-e053-2991aa0a954a	3
197589	diazepam 10 MG Oral Tablet	SCD	32e7bfa1-6060-4041-a0e5-249cacb84ebc	3
197590	diazepam 2 MG Oral Tablet	SCD	32e7bfa1-6060-4041-a0e5-249cacb84ebc	3
197591	diazepam 5 MG Oral Tablet	SCD	32e7bfa1-6060-4041-a0e5-249cacb84ebc	3
197589	diazePAM 10 MG Oral Tablet	PSN	e5f4151c-ee35-4ff7-8374-ab202642373c	2
197589	diazepam 10 MG Oral Tablet	SCD	e5f4151c-ee35-4ff7-8374-ab202642373c	2
197589	diazePAM 10 MG Oral Tablet	PSN	5111654f-a026-71b2-e063-6294a90ab49b	1
197589	diazePAM 10 MG Oral Tablet	PSN	59b78f7b-5cd1-2a69-e053-2a91aa0aa5e2	1
197589	diazePAM 10 MG Oral Tablet	PSN	82359553-4190-4fa7-ae45-18f6e33770d5	1
197590	diazePAM 2 MG Oral Tablet	PSN	59b78f7b-5cd1-2a69-e053-2a91aa0aa5e2	1
197591	diazePAM 5 MG Oral Tablet	PSN	59b78f7b-5cd1-2a69-e053-2a91aa0aa5e2	1
197589	diazepam 10 MG Oral Tablet	SCD	5111654f-a026-71b2-e063-6294a90ab49b	1
197589	diazepam 10 MG Oral Tablet	SCD	59b78f7b-5cd1-2a69-e053-2a91aa0aa5e2	1
197589	diazepam 10 MG Oral Tablet	SCD	82359553-4190-4fa7-ae45-18f6e33770d5	1
197590	diazepam 2 MG Oral Tablet	SCD	59b78f7b-5cd1-2a69-e053-2a91aa0aa5e2	1
197591	diazepam 5 MG Oral Tablet	SCD	59b78f7b-5cd1-2a69-e053-2a91aa0aa5e2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0172-3927-60	00172392760	100 TABLET in 1 BOTTLE (0172-3927-60)	100 tablet	1986-12-10	0000-00-00	No	No	Current
0172-3927-70	00172392770	500 TABLET in 1 BOTTLE (0172-3927-70)	500 tablet	1986-12-10	0000-00-00	No	No	Current
0172-3927-80	00172392780	1000 TABLET in 1 BOTTLE (0172-3927-80)	1000 tablet	1986-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diazepam Tablets, USP, CIV Rx only	REMEDYREPACK INC.	2026-06-23	HUMAN PRESCRIPTION DRUG LABEL	25
Diazepam Tablets, USP, CIV Rx only	Coupler LLC	2026-05-05	HUMAN PRESCRIPTION DRUG LABEL	1
Diazepam Tablets, USP, CIV Rx only	REMEDYREPACK INC.	2026-03-12	HUMAN PRESCRIPTION DRUG LABEL	21
DIAZEPAM	Direct_Rx	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	18
Diazepam Tablets, USP, CIV Rx only	PD-Rx Pharmaceuticals, Inc.	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	24
Diazepam Tablets, USP, CIV Rx only	A-S Medication Solutions	2025-06-09	HUMAN PRESCRIPTION DRUG LABEL	34
Diazepam Tablets, USP, CIV Rx only	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-01-27	HUMAN PRESCRIPTION DRUG LABEL	3
Diazepam Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	6
Diazepam Tablets USP CIV Rx only	NuCare Pharmaceuticals,Inc.	2024-06-14	HUMAN PRESCRIPTION DRUG LABEL	3
Diazepam Tablets, USP, CIV Rx only	Preferred Pharmaceuticals, Inc.	2024-04-09	HUMAN PRESCRIPTION DRUG LABEL	16
Diazepam Tablets, USP, CIV Rx only	Bryant Ranch Prepack	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL	12
Diazepam Tablets, USP, CIV Rx only	Teva Pharmaceuticals USA, Inc.	2024-01-31	HUMAN PRESCRIPTION DRUG LABEL	17
Diazepam Tablets, USP, CIV Rx only	Aphena Pharma Solutions - Tennessee, LLC	2022-09-02	HUMAN PRESCRIPTION DRUG LABEL	6
DIAZEPAM TABLETS USP CIV	Proficient Rx LP	2022-08-01	HUMAN PRESCRIPTION DRUG LABEL	4
DIAZEPAM TABLETS USP CIV Rx only	Quality Care Products LLC	2022-04-20	HUMAN PRESCRIPTION DRUG LABEL	5
Diazepam - Redpharm Drug, Inc.	Redpharm Drug, Inc.	2022-01-19	HUMAN PRESCRIPTION DRUG LABEL	22
Diazepam Tablets, USP, CIV Rx only	Bryant Ranch Prepack	2021-12-22	HUMAN PRESCRIPTION DRUG LABEL	1008
Diazepam Tablets USP CIV Rx only	NuCare Pharmaceuticals,Inc.	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL	2
Diazepam Tablets USP CIV Rx only	St Mary's Medical Park Pharmacy \| St. Mary's Medical Park Pharmacy	2020-01-29	HUMAN PRESCRIPTION DRUG LABEL	1
Diazepam Tablets USP CIVRx only	Clinical Solutions Wholesale, LLC	2019-08-20	HUMAN PRESCRIPTION DRUG LABEL	1
945 Diazepam 2 mg 943 Diazepam 5 mg 944 Diazepam 10 mg Diazepam Tablets USP CIV Rx only	Contract Pharmacy Services-PA \| Coupler Enterprises	2017-09-21	HUMAN PRESCRIPTION DRUG LABEL	1