Tussionex Pennkinetic

Product NDC: 53014-548
11-digit product format: 530140548
Labeler code: 53014
Product ID: 53014-548_0503c2c1-238b-4189-9b9c-08e712fa9313
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocodone polistirex and chlorpheniramine polistirex
Dosage form: SUSPENSION, EXTENDED RELEASE
Route: ORAL
Labeler: Unither Manufacturing LLC
Application: NDA019111
Marketing category: NDA
Marketing start: 1987-12-31
Marketing end: 0000-00-00
Substance: HYDROCODONE; CHLORPHENIRAMINE
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	53014-548		I	Inactivated by FDA		2026-10-05
excluded package	package	53014-548	53014-548-01	I	Inactivated by FDA		2026-10-05

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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	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	53014-548-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N019111-001	TUSSIONEX PENNKINETIC	CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL		RLD	1987-12-31

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019111-001	TUSSIONEX PENNKINETIC	EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION, EXTENDED RELEASE / ORAL	RLD	1987-12-31	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
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
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
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419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
a5244f9c-cd67-0e27-d63b-65fd7e584400	Product name	2	20170504
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c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
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e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53014-548-01	2020-01-31	C162847	48780-1	9d75b9d0-5518-f424-e053-dadaa90a57ce	Tussionex ® Pennkinetic ® (hydrocodone polistirex and chlorpheniramine polistirex) Extended-Release Suspension CII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53014-548-01	Tussionex Pennkinetic	1 in 1 CARTON	SUSPENSION, EXTENDED RELEASE	1		7
53014-548-01	Tussionex Pennkinetic	115 mL in 1 BOTTLE, PLASTIC	SUSPENSION, EXTENDED RELEASE	115		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53014-548-01	ML - Milliliter	53014-548	67b5b137-f879-4cd0-a985-19c0e3bc7a0e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
chlorpheniramine	ACTIVE INGREDIENT	3U6IO1965U	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6
hydrocodone	ACTIVE INGREDIENT	6YKS4Y3WQ7	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6
chlorpheniramine	ACTIVE MOIETY	3U6IO1965U	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6
hydrocodone	ACTIVE MOIETY	6YKS4Y3WQ7	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6
ascorbic acid	INACTIVE INGREDIENT	PQ6CK8PD0R	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6
ethylcelluloses	INACTIVE INGREDIENT	7Z8S9VYZ4B	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6
high fructose corn syrup	INACTIVE INGREDIENT	XY6UN3QB6S	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6
polyethylene glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6
sucrose	INACTIVE INGREDIENT	C151H8M554	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6
water	INACTIVE INGREDIENT	059QF0KO0R	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53014-548	TUSSIONEX PENNKINETIC (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [UNITHER MANUFACTURING LLC]	7	Legacy NDC, 2 package rows	20170330_af2caf33-e587-4d80-9523-44e1b565aae2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6YKS4Y3WQ7	HYDROCODONE	125-29-1	HYDROCODONE
3U6IO1965U	CHLORPHENIRAMINE	132-22-9	CHLORPHENIRAMINE

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	af2caf33-e587-4d80-9523-44e1b565aae2	7
1087463	Tussionex Pennkinetic 10 MG / 8 MG in 5 mL 12HR Extended Release Oral Suspension	PSN	af2caf33-e587-4d80-9523-44e1b565aae2	7
1087463	12 HR chlorpheniramine polistirex 1.6 MG/ML / hydrocodone polistirex 2 MG/ML Extended Release Suspension [Tussionex]	SBD	af2caf33-e587-4d80-9523-44e1b565aae2	7
1087459	12 HR chlorpheniramine polistirex 1.6 MG/ML / hydrocodone polistirex 2 MG/ML Extended Release Suspension	SCD	af2caf33-e587-4d80-9523-44e1b565aae2	7
1087459	hydrocodone polistirex 10 MG / chlorpheniramine polistirex 8 MG per 5 ML 12HR Extended Release Oral Suspension	SY	af2caf33-e587-4d80-9523-44e1b565aae2	7
1087463	Tussionex Pennkinetic ER (chlorpheniramine polistirex 1.6 MG/ML / hydrocodone polistirex 2 MG/ML) 12 HR Extended Release Suspension	SY	af2caf33-e587-4d80-9523-44e1b565aae2	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53014-548-01	53014054801	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tussionex ® Pennkinetic ® (hydrocodone polistirex and chlorpheniramine polistirex) Extended-Release Suspension CII	Unither Manufacturing LLC	2017-01-20	HUMAN PRESCRIPTION DRUG LABEL	7