Diazepam

Product NDC
43063-718
11-digit product format
430630718
Labeler code
43063
Product ID
43063-718_e4f6eb59-e534-3cfb-e053-2a95a90acc29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazepam
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA070325
Marketing category
ANDA
Marketing start
1985-09-04
Marketing end
0000-00-00
Substance
DIAZEPAM
Active strength
5 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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43063-718DDiscontinued by firm2026-08-03
excluded packagepackage43063-71843063-718-04DDiscontinued by firm2026-08-03
excluded packagepackage43063-71843063-718-06DDiscontinued by firm2026-08-03
excluded packagepackage43063-71843063-718-09DDiscontinued by firm2026-08-03
excluded packagepackage43063-71843063-718-10DDiscontinued by firm2026-08-03
excluded packagepackage43063-71843063-718-12DDiscontinued by firm2026-08-03
excluded packagepackage43063-71843063-718-15DDiscontinued by firm2026-08-03
excluded packagepackage43063-71843063-718-21DDiscontinued by firm2026-08-03
excluded packagepackage43063-71843063-718-30DDiscontinued by firm2026-08-03
excluded packagepackage43063-71843063-718-60DDiscontinued by firm2026-08-03
excluded packagepackage43063-71843063-718-90DDiscontinued by firm2026-08-03

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 · 11 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage43063-718-04
excluded packagepackage43063-718-12
excluded packagepackage43063-718-30
excluded packagepackage43063-718-60
excluded packagepackage43063-718-06
excluded packagepackage43063-718-10
excluded packagepackage43063-718-15
excluded packagepackage43063-718-90
excluded packagepackage43063-718-21
excluded packagepackage43063-718-09

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

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-048072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070325-001AB18072bd15b7f6…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-718-04EA - Each43063-7186b278732-adfb-4b13-a955-9ccb24c8b25712017-03-06
43063-718-06EA - Each43063-718a1aacf34-734b-48e3-b788-80887ba6c46712016-12-07
43063-718-09EA - Each43063-7183dbacd97-74d5-4275-98c8-ad73c489267312016-12-07
43063-718-10EA - Each43063-718b3faf814-332e-4e1c-961c-0fc1825f693712016-12-07
43063-718-12EA - Each43063-7189ad308d5-7678-4eb8-a25c-837ede81d6a712016-12-07
43063-718-15EA - Each43063-718712a3350-57de-4ca3-b194-00ddd7b1706e12016-12-07
43063-718-21EA - Each43063-718a861fd21-aa2a-4c35-8fa2-14142c2be21012016-12-07
43063-718-30EA - Each43063-718ad7961e4-1b58-4e74-8f41-573b01191a4312016-12-07
43063-718-60EA - Each43063-718fe84ec98-8591-4c5b-9a95-62c158d1d0d612016-12-07
43063-718-90EA - Each43063-718c395fb1a-05ba-42cb-b943-fbef06b6718212016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-718DIAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]18Legacy NDC20241016_cd02d7f0-0fbe-4829-9a05-99a261972805.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiazepamDIAZEPAMUnit Dose Solutions, Inc.547c2ad4-113c-7771-e063-6394a90a20732026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMCardinal Health 107, LLCba953b22-f0cd-4be5-9e0e-178bded887272026-04-21Boxed 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
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
DiazepamDIAZEPAMMylan Pharmaceuticals Inc.c397a9da-862f-4f3f-8109-7d21691de53a2023-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-718-04430630718044 TABLET in 1 BOTTLE, PLASTIC (43063-718-04) 4 tablet2016-12-010000-00-00NoNoCurrent
43063-718-06430630718066 TABLET in 1 BOTTLE, PLASTIC (43063-718-06) 6 tablet2016-10-240000-00-00NoNoCurrent
43063-718-09430630718099 TABLET in 1 BOTTLE, PLASTIC (43063-718-09) 9 tablet2016-10-240000-00-00NoNoCurrent
43063-718-104306307181010 TABLET in 1 BOTTLE, PLASTIC (43063-718-10) 10 tablet2016-10-240000-00-00NoNoCurrent
43063-718-124306307181212 TABLET in 1 BOTTLE, PLASTIC (43063-718-12) 12 tablet2016-10-240000-00-00NoNoCurrent
43063-718-154306307181515 TABLET in 1 BOTTLE, PLASTIC (43063-718-15) 15 tablet2016-10-240000-00-00NoNoCurrent
43063-718-214306307182121 TABLET in 1 BOTTLE, PLASTIC (43063-718-21) 21 tablet2016-10-240000-00-00NoNoCurrent
43063-718-304306307183030 TABLET in 1 BOTTLE, PLASTIC (43063-718-30) 30 tablet2016-10-120000-00-00NoNoCurrent
43063-718-604306307186060 TABLET in 1 BOTTLE, PLASTIC (43063-718-60) 60 tablet2016-10-240000-00-00NoNoCurrent
43063-718-904306307189090 TABLET in 1 BOTTLE, PLASTIC (43063-718-90) 90 tablet2016-10-240000-00-00NoNoCurrent