Hydrocodone Polistirex and Chlorpheniramine Polistirex

Product NDC
17856-0087
11-digit product format
178560087
Labeler code
17856
Product ID
17856-0087_006b0771-3a21-4603-bf6b-dcd19abb29ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Polistirex and Chlorpheniramine Polistirex
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA091632
Marketing category
ANDA
Marketing start
2015-03-06
Marketing end
0000-00-00
Substance
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE
Active strength
8 mg/5mL; mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2024-12-31
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
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
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
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0087-1Hydrocodone Polistirex and Chlorpheniramine Polistirexextended-release5 mL in 1 CUP, UNIT-DOSESUSPENSION, EXTENDED RELEASE57
17856-0087-1Hydrocodone Polistirex and Chlorpheniramine Polistirexextended-release72 in 1 BOX, UNIT-DOSESUSPENSION, EXTENDED RELEASE727
17856-0087-2Hydrocodone Polistirex and Chlorpheniramine Polistirexextended-release1 in 1 CUP, UNIT-DOSESUSPENSION, EXTENDED RELEASE17
17856-0087-3Hydrocodone Polistirex and Chlorpheniramine Polistirexextended-release5 in 1 BOX, UNIT-DOSESUSPENSION, EXTENDED RELEASE57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0087-1ML - Milliliter17856-00878839a957-cfa1-4395-8a96-ccb68fa7d12b12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0087HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORP.]7Legacy NDC, 4 package rows20230111_9445fb20-9601-44e8-ac08-b27e1e214755.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087459HYDROcodone polistirex 10 MG / chlorpheniramine polistirex 8 MG in 5 mL 12HR Extended Release Oral SuspensionPSN9445fb20-9601-44e8-ac08-b27e1e2147557
108745912 HR chlorpheniramine polistirex 1.6 MG/ML / hydrocodone polistirex 2 MG/ML Extended Release SuspensionSCD9445fb20-9601-44e8-ac08-b27e1e2147557
1087459hydrocodone polistirex 10 MG / chlorpheniramine polistirex 8 MG per 5 ML 12HR Extended Release Oral SuspensionSY9445fb20-9601-44e8-ac08-b27e1e2147557

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17856-0087-11785600870172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0087-1) > 5 mL in 1 CUP, UNIT-DOSE2021-01-110000-00-00NoNoCurrent
17856-0087-2178560087021 BOX, UNIT-DOSE in 1 CUP, UNIT-DOSE (17856-0087-2) > 5 BOX, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0087-3) > 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0087-1) > 5 mL in 1 CUP, UNIT-DOSE2023-01-100000-00-00NoNoCurrent
17856-0087-3178560087035 BOX, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0087-3) > 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0087-1) > 5 mL in 1 CUP, UNIT-DOSE2022-08-150000-00-00NoNoCurrent