Clonidine Hydrochloride

Product NDC
60687-113
11-digit product format
606870113
Labeler code
60687
Product ID
60687-113_16c59ca8-fc05-de71-e063-6294a90ab3fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA070974
Marketing category
ANDA
Marketing start
2020-07-29
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.1 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [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
A070974-001CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070974-001AB

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 UTC2026-02A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16cb3db0bc1861…

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 UTC2026-02A070974-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070974-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070974-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070974-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070974-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070974-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070974-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070974-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070974-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070974-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070974-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070974-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070974-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070974-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070974-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070974-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070974-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070974-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070974-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070974-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070974-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A070974-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070974-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070974-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070974-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A070974-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070974-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070974-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070974-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070974-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070974-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070974-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070974-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070974-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070974-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070974-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070974-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070974-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070974-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070974-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W76I6XXF06Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
884173Internal RxNorm lookup
884185Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b4733c99-656d-4049-9422-3732492dd6edAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45c8ba14-e378-46f0-b21f-1aad8e08c613Product name120250221
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name920190618
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name520171212
48f5a4fd-7cdc-dc04-771d-ce7a47326789Product name220150123
624cf764-e200-44b5-83c2-84526255adb5Product name120150107
47972e1b-c905-eeee-5e77-eb4538ad833cProduct name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-113-01Clonidine Hydrochloride100 in 1 BOX, UNIT-DOSETABLET1007
60687-113-11Clonidine Hydrochloride1 in 1 BLISTER PACKTABLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-113-01EA - Each60687-113e32af83e-14e8-4c38-ba7e-e874b5fbcb0b12020-08-06
60687-113-11EA - Each60687-113973acb92-00d9-447c-a4bb-73a2b25fc1f212020-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-113CLONIDINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 2 package rows20240522_b4733c99-656d-4049-9422-3732492dd6ed.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.7ec53e25-c50a-48b4-82b0-c0b3626f31dc2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDECardinal Health 107, LLCdf62817d-2f50-4c27-aaa8-a22f0290c94f2026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDENorthwind Health Company, LLC66dc3cf0-d6bd-436c-9a7f-7477575b32602026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEBluePoint Laboratories1ea412db-d847-4094-be83-e3bd7328537a2025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.00c6d67a-bb11-4884-9eeb-4e1b8701a08b2025-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.df4b087e-a81a-1321-e053-2995a90a2b9f2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.7cd64137-09d7-7a00-e053-2a91aa0a06ae2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs0bde4636-7f34-467e-b9b9-8d281145177d2024-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEAmerican Health Packagingb4733c99-656d-4049-9422-3732492dd6ed2024-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
ndc (product): 60687-113
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEActavis Pharma, Inc.a842ab83-3531-44dd-a8a8-64dd89e870262022-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSNb4733c99-656d-4049-9422-3732492dd6ed7
884185cloNIDine HCl 0.2 MG Oral TabletPSNb4733c99-656d-4049-9422-3732492dd6ed7
884173clonidine hydrochloride 0.1 MG Oral TabletSCDb4733c99-656d-4049-9422-3732492dd6ed7
884185clonidine hydrochloride 0.2 MG Oral TabletSCDb4733c99-656d-4049-9422-3732492dd6ed7
884173clonidine HCl 100 MCG Oral TabletSYb4733c99-656d-4049-9422-3732492dd6ed7
884185clonidine HCl 200 MCG Oral TabletSYb4733c99-656d-4049-9422-3732492dd6ed7
884173cloNIDine HCl 0.1 MG Oral TabletPSNdf62817d-2f50-4c27-aaa8-a22f0290c94f6
884185cloNIDine HCl 0.2 MG Oral TabletPSNdf62817d-2f50-4c27-aaa8-a22f0290c94f6
884173clonidine hydrochloride 0.1 MG Oral TabletSCDdf62817d-2f50-4c27-aaa8-a22f0290c94f6
884185clonidine hydrochloride 0.2 MG Oral TabletSCDdf62817d-2f50-4c27-aaa8-a22f0290c94f6
884173clonidine HCl 100 MCG Oral TabletSYdf62817d-2f50-4c27-aaa8-a22f0290c94f6
884185clonidine HCl 200 MCG Oral TabletSYdf62817d-2f50-4c27-aaa8-a22f0290c94f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-113-0160687011301100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-113-01) / 1 TABLET in 1 BLISTER PACK (60687-113-11) 100 blister pack2020-07-290000-00-00NoNoCurrent
60687-113-11606870113111 in 1 BLISTER PACKHistorical