FDA.reportPublic FDA data

Dexmedetomidine Hydrochloride

Product NDC
70121-1711
11-digit product format
701211711
Labeler code
70121
Product ID
70121-1711_80e0f31d-7579-4355-baba-5a565a61242e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmedetomidine Hydrochloride in Sodium Chloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA216604
Marketing category
ANDA
Marketing start
2023-05-19
Substance
DEXMEDETOMIDINE HYDROCHLORIDE
Active strength
4 ug/mL
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dexmedetomidine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMEDETOMIDINE HYDROCHLORIDE4 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1018WH7F9I
Rxcui1718906, 1718909

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ec136f1-cd53-4b90-826e-3eaeec54dca0Product name220250401
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
acae4bed-c293-9f7e-61b9-d68b8475ed3aProduct name220230104
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
536fa340-f745-6c4e-1ad7-a3c414722bccProduct name920170706
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-1711-2Dexmedetomidine Hydrochloride1 in 1 POUCHINJECTION114
70121-1711-2Dexmedetomidine Hydrochloride15 in 1 CARTONINJECTION1514
70121-1711-9Dexmedetomidine Hydrochloride1 in 1 POUCHINJECTION114
70121-1711-9Dexmedetomidine Hydrochloride24 in 1 CARTONINJECTION2414

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1711-1ML - Milliliter70121-17111b4f5a14-dde5-4cb2-913c-8eac67a9a81012023-09-05
70121-1711-9ML - Milliliter70121-171193877027-3459-41b2-935a-adfc1b558ca812023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1711DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE HYDROCHLORIDE IN SODIUM CHLORIDE) INJECTION [AMNEAL PHARMACEUTICALS LLC]13Current NDC, 4 package rows20241113_4df8cc35-fc80-4438-b982-9c4b7d17bad2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718906dexmedeTOMIDine HCl 200 MCG in 50 ML InjectionPSN4df8cc35-fc80-4438-b982-9c4b7d17bad214
1718909dexmedeTOMIDine HCl 400 MCG in 100 ML InjectionPSN4df8cc35-fc80-4438-b982-9c4b7d17bad214
1718909100 ML dexmedetomidine 0.004 MG/ML InjectionSCD4df8cc35-fc80-4438-b982-9c4b7d17bad214
171890650 ML dexmedetomidine 0.004 MG/ML InjectionSCD4df8cc35-fc80-4438-b982-9c4b7d17bad214
1718906dexmedetomidine (as dexmedetomidine HCl) 200 MCG per 50 ML InjectionSY4df8cc35-fc80-4438-b982-9c4b7d17bad214
1718909dexmedetomidine (as dexmedetomidine HCl) 400 MCG per 100 ML InjectionSY4df8cc35-fc80-4438-b982-9c4b7d17bad214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70121-1711-27012117110215 POUCH in 1 CARTON (70121-1711-2) / 1 BAG in 1 POUCH / 50 mL in 1 BAG15 pouch2024-01-08NoNoCurrent
70121-1711-97012117110924 POUCH in 1 CARTON (70121-1711-9) / 1 BAG in 1 POUCH / 50 mL in 1 BAG24 pouch2023-05-19NoNoCurrent