Diazepam

Product NDC
71610-270
11-digit product format
716100270
Labeler code
71610
Product ID
71610-270_1ce73ca7-a651-40ea-9629-0e664017b5c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA071321
Marketing category
ANDA
Marketing start
1986-12-10
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071321-001DIAZEPAMDIAZEPAM5MGTABLET / ORALAB1986-12-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071321-001AB

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-1084e616aacf4f…
2026-08-18 06:07:402026-07A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-103f01610625f2…
2019-09-15 20:21 UTC2019-09A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A071321-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A071321-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071321-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071321-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071321-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071321-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071321-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071321-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071321-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071321-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071321-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071321-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071321-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071321-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071321-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071321-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071321-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071321-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071321-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071321-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071321-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071321-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071321-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071321-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071321-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071321-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071321-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071321-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071321-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071321-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071321-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071321-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071321-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071321-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071321-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071321-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071321-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071321-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071321-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071321-001AB1f41ea6bd6efb…

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
bdb8feda-01c6-45bd-bd66-97196ccce70cAvailable 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
71610-270-15Diazepam15 in 1 BOTTLETABLET151
71610-270-20Diazepam20 in 1 BOTTLETABLET201
71610-270-30Diazepam30 in 1 BOTTLETABLET301
71610-270-45Diazepam45 in 1 BOTTLETABLET451
71610-270-53Diazepam60 in 1 BOTTLETABLET601
71610-270-55Diazepam75 in 1 BOTTLETABLET751
71610-270-60Diazepam90 in 1 BOTTLETABLET901
71610-270-70Diazepam120 in 1 BOTTLETABLET1201
71610-270-75Diazepam150 in 1 BOTTLETABLET1501
71610-270-80Diazepam180 in 1 BOTTLETABLET1801
71610-270-90Diazepam240 in 1 BOTTLETABLET2401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-270-15EA - Each71610-2706a4f53e2-7992-4141-90d8-dc143213edac12019-06-19
71610-270-20EA - Each71610-2702e6f2818-9cf7-4076-a1ac-861ce8c15a8412019-06-19
71610-270-30EA - Each71610-270c4123ff5-310e-4c80-adfb-7bb64c8af9b412019-06-19
71610-270-45EA - Each71610-270dffa8352-237e-44ee-989f-474c9dd9901d12019-06-19
71610-270-53EA - Each71610-2709dc491ee-e725-4920-92f4-8841b0ea926112019-06-19
71610-270-55EA - Each71610-2702244bf59-e96d-4905-8d07-525de2482ae512019-06-19
71610-270-60EA - Each71610-27077ea2322-5664-42db-a5f4-5cf53cc66f4212019-06-19
71610-270-70EA - Each71610-270bc83b122-93f0-43ad-8fb7-4e26354b0ef412019-06-19
71610-270-75EA - Each71610-270453ef934-de1d-4b5b-8c0c-d65bd0c8ad0b12019-06-19
71610-270-80EA - Each71610-270b4b865ac-4435-45b3-9e29-acfa57ce12e612019-06-19
71610-270-90EA - Each71610-2707695d4cb-d3ff-4196-86d3-e9b9ee59347512019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-270DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 11 package rows20190515_bdb8feda-01c6-45bd-bd66-97196ccce70c.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
DiazepamDIAZEPAMREMEDYREPACK INC.20e08b97-bb89-4129-a228-8ad9cf35a1d32026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMCoupler LLC5114ae6e-8cae-e96f-e063-6294a90a9e602026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DIAZEPAMDIAZEPAMDirect_Rx4b0c9c0a-4274-4d56-a7a4-bc497916469c2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.2483426d-3782-432a-8b8d-86c06ef0de4a2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMA-S Medication Solutionsb47dc708-e83b-4224-bdb5-c9b7abd35cfb2025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMAsclemed USA, Inc.32e7bfa1-6060-4041-a0e5-249cacb84ebc2025-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMNuCare Pharmaceuticals,Inc.823093aa-d0cd-53c9-e053-2a91aa0a52352024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMNuCare Pharmaceuticals,Inc.8b3cc5c9-91bd-7467-e053-2a95a90a44b82024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMBryant Ranch Prepack6abedac6-5133-47b2-a0e3-e239e0a2254b2024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMBryant Ranch Prepacke8e4d5f5-3b4c-4c0f-a818-9da86389473c2024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMA-S Medication Solutionsaf9a7906-4dca-4c1f-b16b-9b666a86b3632024-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMTeva Pharmaceuticals USA, Inc.48aa32cb-047a-414a-822e-82a5f26d88172024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMClinical Solutions Wholesale, LLC87b0fbb9-0c05-4ab0-8efe-7ffcae85b8682024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMProficient Rx LPe7542d46-2586-4225-b07d-2633116bfa0a2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMAphena Pharma Solutions - Tennessee, LLCbdb8feda-01c6-45bd-bd66-97196ccce70c2019-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
ndc (product): 71610-270

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197591diazePAM 5 MG Oral TabletPSNbdb8feda-01c6-45bd-bd66-97196ccce70c1
197591diazepam 5 MG Oral TabletSCDbdb8feda-01c6-45bd-bd66-97196ccce70c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-270-157161002701515 TABLET in 1 BOTTLE (71610-270-15) 15 tablet2019-05-010000-00-00NoNoCurrent
71610-270-207161002702020 TABLET in 1 BOTTLE (71610-270-20) 20 tablet2019-05-010000-00-00NoNoCurrent
71610-270-307161002703030 TABLET in 1 BOTTLE (71610-270-30) 30 tablet2019-05-010000-00-00NoNoCurrent
71610-270-457161002704545 TABLET in 1 BOTTLE (71610-270-45) 45 tablet2019-05-010000-00-00NoNoCurrent
71610-270-537161002705360 TABLET in 1 BOTTLE (71610-270-53) 60 tablet2019-05-010000-00-00NoNoCurrent
71610-270-557161002705575 TABLET in 1 BOTTLE (71610-270-55) 75 tablet2019-05-010000-00-00NoNoCurrent
71610-270-607161002706090 TABLET in 1 BOTTLE (71610-270-60) 90 tablet2019-05-010000-00-00NoNoCurrent
71610-270-7071610027070120 TABLET in 1 BOTTLE (71610-270-70) 120 tablet2019-05-010000-00-00NoNoCurrent
71610-270-7571610027075150 TABLET in 1 BOTTLE (71610-270-75) 150 tablet2019-05-010000-00-00NoNoCurrent
71610-270-8071610027080180 TABLET in 1 BOTTLE (71610-270-80) 180 tablet2019-05-010000-00-00NoNoCurrent
71610-270-9071610027090240 TABLET in 1 BOTTLE (71610-270-90) 240 tablet2019-05-010000-00-00NoNoCurrent