Hydrocodone Polistirex and Chlorpheniramine Polisitrex

Product NDC: 17856-0235
11-digit product format: 178560235
Labeler code: 17856
Product ID: 17856-0235_f75c6ba1-6695-4bcb-88ec-63efd2acdf92
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Polistirex and Chlorpheniramine Polisitrex
Dosage form: SUSPENSION, EXTENDED RELEASE
Route: ORAL
Labeler: Atlantic Biologicals Corps
Application: ANDA091632
Marketing category: ANDA
Marketing start: 2012-08-16
Marketing end: 0000-00-00
Substance: HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE
Active strength: 10 mg/5mL; mg/5mL
Pharmacologic classes: Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
DEA schedule: CII
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	17856-0235		I	Inactivated by FDA		2026-08-03
excluded package	package	17856-0235	17856-0235-1	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0235-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0235-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0235-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0235-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0235-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0235-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0235-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0235-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0235-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-0235-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-0235-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-0235-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17856-0235-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-0235-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0235-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	17856-0235-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	17856-0235-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	17856-0235-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	17856-0235-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	17856-0235-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	17856-0235-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	17856-0235-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	AB		2010-10-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	AB		2010-10-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	AB		2010-10-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	AB		2010-10-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	AB		2010-10-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	AB		2010-10-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	AB		2010-10-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	AB		2010-10-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	AB		2010-10-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	AB		2010-10-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	AB		2010-10-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	AB		2010-10-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	AB		2010-10-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL		RS	2010-10-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	AB		2010-10-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	AB		2010-10-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	AB		2010-10-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091632-001	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	AB		2010-10-01	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091632-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091632-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091632-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091632-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091632-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091632-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091632-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091632-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091632-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091632-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091632-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091632-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091632-001	AB	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091632-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091632-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091632-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091632-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
53523715-c529-4d52-b9ff-1e5d76636f53	Product name	2	20210818
31b11e56-5b35-4ab6-a3a8-f0b48973dced	Product name	2	20200611
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
a90f088a-9578-47a2-8f6e-0a9d32aafec6	Product name	1	20181030
f6c90bdc-1674-455a-aadd-1b1b59e5edeb	Product name	2	20181030
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
7855f8e3-562e-4273-8b79-0059c07a71f7	Product name	1	20170901
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
a5244f9c-cd67-0e27-d63b-65fd7e584400	Product name	2	20170504
b654f2d9-ebeb-451d-96ee-22f583344623	Product name	1	20170424
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-0235-1	2020-01-31	C162847	48780-1	9d75b9d0-865c-f424-e053-dadaa90a57ce	Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended Release Oral Suspension CII (10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-0235-1	Hydrocodone Polistirex and Chlorpheniramine Polisitrex	5 mL in 1 CUP, UNIT-DOSE	SUSPENSION, EXTENDED RELEASE	5		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)	INACTIVE INGREDIENT	461P5CJN6T	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
SODIUM ASCORBATE	INACTIVE INGREDIENT	S033EH8359	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
SODIUM POLYSTYRENE SULFONATE	INACTIVE INGREDIENT	1699G8679Z	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
VINYL ACETATE	INACTIVE INGREDIENT	L9MK238N77	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0235	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISITREX SUSPENSION, EXTENDED RELEASE [ATLANTIC BIOLOGICALS CORPS]	2	Legacy NDC, 1 package rows	20150216_566d28f3-4b16-4881-9347-2175e5060ffb.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	Bryant Ranch Prepack	03d40087-b413-4f19-af4a-e0f60b0ff542	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091632 application number: ANDA091632
Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	Bryant Ranch Prepack	e0010aac-2d7e-4dd3-8024-ff0c7f668b77	2025-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091632 application number: ANDA091632
Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	Cranbury Pharmaceuticals, LLC	25f400d9-1d6e-4d38-8f0d-98d471eba73b	2024-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091632 application number: ANDA091632
Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release	HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX	Bryant Ranch Prepack	eecaa52b-f636-4ae4-a60f-d5e2503ab53b	2023-11-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091632 application number: ANDA091632

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NO70W886KK	HYDROCODONE BITARTRATE	34195-34-1	HYDROCODONE BITARTRATE
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1087459	HYDROcodone polistirex 10 MG / chlorpheniramine polistirex 8 MG in 5 mL 12HR Extended Release Oral Suspension	PSN	566d28f3-4b16-4881-9347-2175e5060ffb	2
1087459	12 HR chlorpheniramine polistirex 1.6 MG/ML / hydrocodone polistirex 2 MG/ML Extended Release Suspension	SCD	566d28f3-4b16-4881-9347-2175e5060ffb	2
1087459	hydrocodone polistirex 10 MG / chlorpheniramine polistirex 8 MG per 5 ML 12HR Extended Release Oral Suspension	SY	566d28f3-4b16-4881-9347-2175e5060ffb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
17856-0235-1	17856023501	5 mL in 1 CUP, UNIT-DOSE	5 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Polistirex and Chlorpheniramine Polisitrex	Atlantic Biologicals Corps	2014-10-17	HUMAN PRESCRIPTION DRUG LABEL	2