Hydrocodone Bitartrate and Homatropine Methylbromide

Product NDC
21695-869
11-digit product format
216950869
Labeler code
21695
Product ID
21695-869_95828fad-323e-4510-acbf-6d354b25b887
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Homatropine Methylbromide
Dosage form
SYRUP
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA040613
Marketing category
ANDA
Marketing start
2008-02-08
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE
Active strength
5 mg/5mL; mg/5mL
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA],Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-869-162019-09-24C16284748780-1934fe258-4b6f-48b1-e053-8cdaa90a720aHydrocodone Bitartrate and Homatropine Methylbromide Syrup

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-869-16Hydrocodone Bitartrate and Homatropine Methylbromide473 mL in 1 BOTTLESYRUP4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-869-16ML - Milliliter21695-86971cd132f-5e16-4bcf-80f2-11a9bdcbd63212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HOMATROPINE METHYLBROMIDEACTIVE INGREDIENT68JRS2HC1CHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
HOMATROPINEACTIVE MOIETY8QS6WCL55ZHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
CHERRYINACTIVE INGREDIENTBUC5I9595WHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
SORBITOLINACTIVE INGREDIENT506T60A25RHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-869HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110314_95828fad-323e-4510-acbf-6d354b25b887.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 SolutionPSN95828fad-323e-4510-acbf-6d354b25b8871
992668homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral SolutionSCD95828fad-323e-4510-acbf-6d354b25b8871
992668homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML SyrupSY95828fad-323e-4510-acbf-6d354b25b8871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-869-1621695086916473 mL in 1 BOTTLE473 mlHistorical