FDA.reportPublic FDA data

Diazepam

Product NDC
62135-767
11-digit product format
621350767
Labeler code
62135
Product ID
62135-767_4517b811-0a91-89f5-e063-6294a90a9a30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam Oral
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA206477
Marketing category
ANDA
Marketing start
2016-06-24
Substance
DIAZEPAM
Active strength
5 mg/5mL
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206477-001DIAZEPAMDIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206477-001AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-243f01610625f2…
2019-09-15 20:21 UTC2019-09A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206477-001DIAZEPAM5MG/5MLSOLUTION / ORALAA2016-06-24cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206477-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206477-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206477-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206477-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206477-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206477-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206477-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206477-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206477-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206477-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206477-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206477-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206477-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206477-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206477-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206477-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206477-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206477-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206477-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206477-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206477-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A206477-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206477-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206477-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206477-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A206477-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206477-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206477-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206477-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206477-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206477-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206477-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206477-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206477-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206477-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206477-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206477-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206477-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206477-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206477-001AA1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZEPAM5 mg/5mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309843Internal RxNorm lookup
309844Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cdb839fb-27e5-4a11-aed6-da0a7ab6e996Available 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
62135-767-24Diazepam10 in 1 TRAYSOLUTION105
62135-767-24Diazepam2 in 1 BOXSOLUTION25
62135-767-45Diazepam5 mL in 1 CUPSOLUTION55
62135-767-47Diazepam473 mL in 1 BOTTLESOLUTION4735

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-767-24ML - Milliliter62135-767020751bb-bfda-43b1-be7a-e7d157cf3c7812024-09-09
62135-767-45ML - Milliliter62135-767f9d91f94-53bb-4dc7-b821-41352c6f877712024-09-09
62135-767-47ML - Milliliter62135-767e072836c-dfc0-4bdb-8dce-799b8c1f893412022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-767DIAZEPAM (DIAZEPAM ORAL SOLUTION (CONCENTRATE)) SOLUTION DIAZEPAM (DIAZEPAM ORAL) SOLUTION [CHARTWELL RX, LLC]4Current NDC, Legacy NDC, 4 package rows20241024_cdb839fb-27e5-4a11-aed6-da0a7ab6e996.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiazepamDIAZEPAM ORALChartwell RX, LLCcdb839fb-27e5-4a11-aed6-da0a7ab6e9962025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206477
application number: ANDA206477
ndc (product): 62135-767
DiazepamDIAZEPAM ORALChartwell Governmental & Specialty RX, LLC.167ee280-be68-4a28-a7d8-de41df14bc482025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206477
application number: ANDA206477

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309844diazePAM 5 MG in 1 mL Concentrate for Oral SolutionPSNcdb839fb-27e5-4a11-aed6-da0a7ab6e9965
309843diazePAM 5 MG in 5 mL Oral SolutionPSNcdb839fb-27e5-4a11-aed6-da0a7ab6e9965
309843diazepam 1 MG/ML Oral SolutionSCDcdb839fb-27e5-4a11-aed6-da0a7ab6e9965
309844diazepam 5 MG/ML Oral SolutionSCDcdb839fb-27e5-4a11-aed6-da0a7ab6e9965
309844diazepam 5 MG per 1 ML Concentrate for Oral SolutionSYcdb839fb-27e5-4a11-aed6-da0a7ab6e9965
309843diazepam 5 MG per 5 ML Oral SolutionSYcdb839fb-27e5-4a11-aed6-da0a7ab6e9965

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-767-24621350767242 TRAY in 1 BOX (62135-767-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-767-45) 2 tray2024-07-12NoNoCurrent
62135-767-45621350767455 mL in 1 CUP5 mlHistorical
62135-767-4762135076747473 mL in 1 BOTTLE (62135-767-47) 473 ml2022-08-170000-00-00NoNoCurrent