Diazepam

Product NDC
71335-2239
Requested package NDC
71335-2239-3
11-digit product format
713352239
Labeler code
71335
Product ID
71335-2239_a4623d8d-0257-43db-bd8a-be652068231a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA070325
Marketing category
ANDA
Marketing start
1985-09-04
Substance
DIAZEPAM
Active strength
5 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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070325-001DIAZEPAMDIAZEPAM10MGTABLET / ORALAB1985-09-04
A070325-002DIAZEPAMDIAZEPAM2MGTABLET / ORALAB1985-09-04
A070325-003DIAZEPAMDIAZEPAM5MGTABLET / ORALAB1985-09-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070325-001AB
A070325-002AB
A070325-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-0484e616aacf4f…
2026-09-14 22:38:342026-08A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-0484e616aacf4f…
2026-09-14 22:38:342026-08A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-0484e616aacf4f…
2026-08-18 06:07:402026-07A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04caaa826d4ba7…
2026-08-18 06:07:402026-07A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04caaa826d4ba7…
2026-08-18 06:07:402026-07A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A070325-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A070325-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A070325-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A070325-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070325-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070325-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070325-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070325-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070325-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070325-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070325-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070325-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070325-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A070325-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A070325-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-001AB1301d65b070ca…

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZEPAM5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q3JTX2Q7TUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197591Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9424ce71-f04c-4d70-89de-b7858931c53dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
69057c52-36b0-21c0-02d6-d697be15c03cProduct name420260305
da74e203-d183-4c62-8511-c3ef56b5964eProduct name120250213
2792dd44-ff30-4712-8b05-1850c2b4d307Product name320250211
2fd3ebb9-86c1-64e3-e9b6-3c2ba01c6876Product name220250102
0f898f8b-23f1-b816-6bfe-c7f8aac7e42bProduct name220240529
2c487d7e-cbfc-4699-9c83-5c1c7521cde9Product name120200610
02ac201d-7ee6-00c9-f963-81bb5a506b68Product name320160816

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2239-0Diazepam120 in 1 BOTTLE, PLASTICTABLET120102
71335-2239-1Diazepam12 in 1 BOTTLE, PLASTICTABLET12102
71335-2239-2Diazepam15 in 1 BOTTLE, PLASTICTABLET15102
71335-2239-3Diazepam20 in 1 BOTTLE, PLASTICTABLET20102
71335-2239-4Diazepam30 in 1 BOTTLE, PLASTICTABLET30102
71335-2239-5Diazepam60 in 1 BOTTLE, PLASTICTABLET60102
71335-2239-6Diazepam90 in 1 BOTTLE, PLASTICTABLET90102
71335-2239-7Diazepam10 in 1 BOTTLE, PLASTICTABLET10102
71335-2239-8Diazepam2 in 1 BOTTLE, PLASTICTABLET2102
71335-2239-9Diazepam1 in 1 BOTTLE, PLASTICTABLET1102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2239-0EA - Each71335-22397ec09f96-4dec-4731-a4e6-b235e6fb18e112026-03-17
71335-2239-1EA - Each71335-2239b060891a-d190-4e91-b18e-0159fbbaa91612026-03-17
71335-2239-2EA - Each71335-22393a5a1449-40f2-434d-87cd-397c1e10fab912026-03-17
71335-2239-3EA - Each71335-2239278e0ef7-727d-4613-b038-6c00a54cec5a12026-03-17
71335-2239-4EA - Each71335-22398a769985-716e-42d7-bc4e-7030114efb5012026-03-17
71335-2239-5EA - Each71335-2239cf1388bc-83dd-471d-91ba-9761b719570012026-03-17
71335-2239-6EA - Each71335-2239eff9c906-c416-42c9-bf63-97f51f9b206e12025-06-13
71335-2239-7EA - Each71335-2239715d7072-88bf-4805-80aa-95581250306c12026-03-17
71335-2239-8EA - Each71335-223924c41f7d-c8cf-47e8-9a49-f2486111628a12025-05-14
71335-2239-9EA - Each71335-22394391dbb3-4465-4432-9c60-3e7a5903e1fa12026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2239DIAZEPAM TABLET [BRYANT RANCH PREPACK]102Current NDC, 10 package rows20240824_9424ce71-f04c-4d70-89de-b7858931c53d.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiazepamDIAZEPAMCardinal Health 107, LLCba953b22-f0cd-4be5-9e0e-178bded887272026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMUnit Dose Solutions, Inc.547c2ad4-113c-7771-e063-6394a90a20732026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMPreferred Pharmaceuticals Inc.6dcbb5e9-1e8f-4069-9244-adb46356714d2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMPreferred Pharmaceuticals Inc.7646785b-dabc-482d-bf42-06177f00aca22026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMSafecor Health, LLC8b51f4b3-a5e8-4400-b624-ac0c47630c862026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMDirect_Rx181cc7ac-5129-2200-e063-6394a90afd3a2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMA-S Medication Solutions01f04ee4-fff9-499a-8213-984e163680842025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.c2768add-5e01-4ff4-afa3-230380d59a1f2025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMMylan Institutional Inc.b326c66d-5762-4d16-933c-619fa2088ccd2025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMAdvanced Rx of Tennessee, LLC2d322c6a-7f7e-1cc4-e063-6294a90a8e2e2025-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMBryant Ranch Prepack9424ce71-f04c-4d70-89de-b7858931c53d2024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
ndc (package): 71335-2239-3
ndc (product): 71335-2239
ndc11 (package): 71335223903
DiazepamDIAZEPAMBryant Ranch Prepack632d7e96-d32c-45b8-86cf-f18ec2b354852024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMDirect_rx2047f721-6a05-c391-e063-6394a90a4ed72024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMClinical Solutions Wholesale, LLC8b4946b3-ae6c-4174-bbd8-0b8ed2c8fdf32024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMBryant Ranch Prepackf2fc6f38-d627-4fb3-9be2-5e119ee7e1e12023-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197591diazePAM 5 MG Oral TabletPSN9424ce71-f04c-4d70-89de-b7858931c53d102
197591diazepam 5 MG Oral TabletSCD9424ce71-f04c-4d70-89de-b7858931c53d102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2239-37133522390320 TABLET in 1 BOTTLE, PLASTIC (71335-2239-3) 20 tablet2023-09-22NoNoCurrent