FDA.reportPublic FDA data

Hydromet

Product NDC
0472-1030
11-digit product format
004721030
Labeler code
0472
Product ID
0472-1030_7937f983-1f1c-475b-ab10-76a582d1bedd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocodone bitartrate and homatropine methylbromide
Dosage form
SOLUTION
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA088017
Marketing category
ANDA
Marketing start
2002-09-30
Marketing end
2026-08-31
Substance
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Active strength
1.5; 5 mg/5mL; mg/5mL
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydromet

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMATROPINE METHYLBROMIDE1.5 mg/5mL
HYDROCODONE BITARTRATE5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii68JRS2HC1C, NO70W886KK
Rxcui992668, 992675

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
a5244f9c-cd67-0e27-d63b-65fd7e584400Product name220170504
b654f2d9-ebeb-451d-96ee-22f583344623Product name120170424
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0472-1030-16Hydromet473 mL in 1 BOTTLESOLUTION47328

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-1030-16ML - Milliliter0472-10301cf434c7-ea5b-48ff-99c3-e243c67fbf0e12013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HOMATROPINE METHYLBROMIDEACTIVE INGREDIENT68JRS2HC1CHYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]7
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]7
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]7
METHYLHOMATROPINEACTIVE MOIETYP97OGJ7L1LHYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]7
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]7
CHERRYINACTIVE INGREDIENTBUC5I9595WHYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]7
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LHYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]7
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYHYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]7
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUHYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]7
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRHYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]7
SUCROSEINACTIVE INGREDIENTC151H8M554HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]7
WATERINACTIVE INGREDIENT059QF0KO0RHYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-1030HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SOLUTION [ACTAVIS PHARMA, INC.]26Current NDC, Legacy NDC, 1 package rows20240616_a324c912-a3ef-4296-b9a8-b0fec687eb06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992668HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral SolutionPSNa324c912-a3ef-4296-b9a8-b0fec687eb0628
992675Hydromet 5 MG / 1.5 MG in 5 mL Oral SolutionPSNa324c912-a3ef-4296-b9a8-b0fec687eb0628
992675homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution [Hydromet]SBDa324c912-a3ef-4296-b9a8-b0fec687eb0628
992668homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral SolutionSCDa324c912-a3ef-4296-b9a8-b0fec687eb0628
992668homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML SyrupSYa324c912-a3ef-4296-b9a8-b0fec687eb0628
992675Hydromet (homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG) per 5 ML SyrupSYa324c912-a3ef-4296-b9a8-b0fec687eb0628

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-1030-1600472103016473 mL in 1 BOTTLE (0472-1030-16) 473 ml2002-09-302026-08-31NoNoCurrent