Dexamethasone

Product NDC
68047-702
11-digit product format
680470702
Labeler code
68047
Product ID
68047-702_4134ccdd-0287-cdf7-e063-6394a90a766d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexamethasone 1.5 mg
Dosage form
TABLET
Route
ORAL
Labeler
Larken Laboratories, Inc.
Application
ANDA201270
Marketing category
ANDA
Marketing start
2017-09-01
Substance
DEXAMETHASONE
Active strength
1.5 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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
A201270-001DEXAMETHASONEDEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201270-001AB

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 · 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 UTC2026-02A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-173f01610625f2…
2019-09-15 20:21 UTC2019-09A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201270-001DEXAMETHASONE1.5MGTABLET / ORALAB2017-07-17cb3db0bc1861…

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 UTC2026-02A201270-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201270-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201270-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201270-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201270-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201270-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201270-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201270-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201270-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201270-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201270-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201270-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201270-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201270-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201270-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201270-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201270-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201270-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201270-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201270-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201270-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A201270-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201270-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201270-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201270-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A201270-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201270-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201270-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201270-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201270-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201270-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201270-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201270-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201270-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A201270-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A201270-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201270-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201270-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201270-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201270-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Dexamethasone
Brand name suffix
1.5 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE1.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7S5I7G3JQLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197580Internal RxNorm lookup
759481Internal RxNorm lookup
759697Internal RxNorm lookup
846192Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7b997c26-e6a3-403c-93fb-b1290cf5dbadAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68047-702-01Dexamethasone1.5 mg100 in 1 BOTTLETABLET10011
68047-702-21Dexamethasone1.5 mg21 in 1 DOSE PACKTABLET2110
68047-702-35Dexamethasone1.5 mg35 in 1 DOSE PACKTABLET3510
68047-702-51Dexamethasone1.5 mg51 in 1 DOSE PACKTABLET5110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68047-702-01EA - Each68047-702480186a3-6d07-490b-be0e-539cdbf9e1c212017-09-11
68047-702-21EA - Each68047-702724de507-da1c-41ea-912d-a2d72d568ee512018-08-13
68047-702-35EA - Each68047-7020b6a0c2b-103d-44d0-8388-06a4de976ac912018-08-13
68047-702-51EA - Each68047-702fcd53bc1-35a1-4f65-b26e-cd11a070129612018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68047-702DEXAMETHASONE 1.5 MG TABLET [LARKEN LABORATORIES, INC.]10Current NDC, Legacy NDC, 1 package rows20240614_fcc75691-974e-4a67-b9d7-64dde72b5595.zip
68047-702DEXAMETHASONE 1.5 MG TABLET [LARKEN LABORATORIES, INC.]9Current NDC, Legacy NDC, 3 package rows20240710_7b997c26-e6a3-403c-93fb-b1290cf5dbad.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexamethasoneDEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLC01cfaa3e-5e30-18fa-e063-6394a90a084e2025-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201270
application number: ANDA201270
Dexamethasone 1.5 mgDEXAMETHASONE 1.5 MGLarken Laboratories, Inc.7b997c26-e6a3-403c-93fb-b1290cf5dbad2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201270
application number: ANDA201270
ndc (product): 68047-702
Dexamethasone 1.5 mgDEXAMETHASONE 1.5 MGLarken Laboratories, Inc.fcc75691-974e-4a67-b9d7-64dde72b55952025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201270
application number: ANDA201270
ndc (product): 68047-702
DexamethasoneDEXAMETHASONEProficient Rx LP45fd8030-dbe3-4da4-9d0a-6549cf4f73592024-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201270
application number: ANDA201270
Dexamethasone 1.5 mgDEXAMETHASONE 1.5 MGProficient Rx LP42db0356-3948-444c-bda3-1226b4ca89852024-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201270
application number: ANDA201270

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
846192{21 (dexamethasone 1.5 MG Oral Tablet) } PackGPCKfcc75691-974e-4a67-b9d7-64dde72b559511
759697{35 (dexamethasone 1.5 MG Oral Tablet) } PackGPCKfcc75691-974e-4a67-b9d7-64dde72b559511
759481{51 (dexamethasone 1.5 MG Oral Tablet) } PackGPCKfcc75691-974e-4a67-b9d7-64dde72b559511
197580dexAMETHasone 1.5 MG Oral TabletPSNfcc75691-974e-4a67-b9d7-64dde72b559511
759697dexAMETHasone 1.5 MG Tablet 10 Day 35 Count PackPSNfcc75691-974e-4a67-b9d7-64dde72b559511
759481dexAMETHasone 1.5 MG Tablet 13 Day 51 Count PackPSNfcc75691-974e-4a67-b9d7-64dde72b559511
846192dexAMETHasone 1.5 MG Tablet 6 Day 21 Count PackPSNfcc75691-974e-4a67-b9d7-64dde72b559511
197580dexamethasone 1.5 MG Oral TabletSCDfcc75691-974e-4a67-b9d7-64dde72b559511
846192{21 (dexamethasone 1.5 MG Oral Tablet) } PackGPCK7b997c26-e6a3-403c-93fb-b1290cf5dbad10
759697{35 (dexamethasone 1.5 MG Oral Tablet) } PackGPCK7b997c26-e6a3-403c-93fb-b1290cf5dbad10
759481{51 (dexamethasone 1.5 MG Oral Tablet) } PackGPCK7b997c26-e6a3-403c-93fb-b1290cf5dbad10
197580dexAMETHasone 1.5 MG Oral TabletPSN7b997c26-e6a3-403c-93fb-b1290cf5dbad10
759697dexAMETHasone 1.5 MG Tablet 10 Day 35 Count PackPSN7b997c26-e6a3-403c-93fb-b1290cf5dbad10
759481dexAMETHasone 1.5 MG Tablet 13 Day 51 Count PackPSN7b997c26-e6a3-403c-93fb-b1290cf5dbad10
846192dexAMETHasone 1.5 MG Tablet 6 Day 21 Count PackPSN7b997c26-e6a3-403c-93fb-b1290cf5dbad10
197580dexamethasone 1.5 MG Oral TabletSCD7b997c26-e6a3-403c-93fb-b1290cf5dbad10
846192{21 (dexamethasone 1.5 MG Oral Tablet) } PackGPCK42db0356-3948-444c-bda3-1226b4ca89851
197580dexAMETHasone 1.5 MG Oral TabletPSN42db0356-3948-444c-bda3-1226b4ca89851
846192dexAMETHasone 1.5 MG Tablet 6 Day 21 Count PackPSN42db0356-3948-444c-bda3-1226b4ca89851
197580dexamethasone 1.5 MG Oral TabletSCD42db0356-3948-444c-bda3-1226b4ca89851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68047-702-0168047070201100 TABLET in 1 BOTTLE (68047-702-01) 100 tablet2017-09-010000-00-00NoNoCurrent
68047-702-216804707022121 TABLET in 1 DOSE PACK (68047-702-21) 21 tablet2018-08-080000-00-00NoNoCurrent
68047-702-356804707023535 TABLET in 1 DOSE PACK (68047-702-35) 35 tablet2018-08-080000-00-00NoNoCurrent
68047-702-516804707025151 TABLET in 1 DOSE PACK (68047-702-51) 51 tablet2018-08-080000-00-00NoNoCurrent