TussiCaps

Product NDC: 0187-0108
Requested package NDC: 0187-0108-20
11-digit product format: 001870108
Labeler code: 0187
Product ID: 0187-0108_7aae25b4-3cc1-4a2d-8bc6-666bdd86a252
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocodone polistirex and chlorpheniramine polistirex
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Bausch Health US LLC
Application: ANDA077273
Marketing category: ANDA
Marketing start: 2011-09-02
Marketing end: 0000-00-00
Substance: HYDROCODONE; CHLORPHENIRAMINE
Active strength: 10 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0187-0108	0187-0108-20	D	Discontinued by firm		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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077273-001	TUSSICAPS	CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL			2007-09-24
A077273-002	TUSSICAPS	CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL			2007-09-24

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL	RS	2007-09-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL	RS	2007-09-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077273-001	TUSSICAPS	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL	RS	2007-09-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077273-002	TUSSICAPS	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE / ORAL		2007-09-24	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-0108-01	EA - Each	0187-0108	b704153f-b615-4888-9435-c65386ce6b3a	1	2014-11-05
0187-0108-20	EA - Each	0187-0108	9e2e63de-9920-4139-b8c3-00648d1881db	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORPHENIRAMINE	ACTIVE INGREDIENT	3U6IO1965U	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
HYDROCODONE	ACTIVE INGREDIENT	6YKS4Y3WQ7	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
D&C BLACK NO. 2	INACTIVE INGREDIENT	4XYU5U00C4	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TUSSICAPS (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) CAPSULE, EXTENDED RELEASE [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	1

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-0108-20	00187010820	20 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0187-0108-20)	2011-09-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TussiCaps ® (Hydrocodone Polistirex and Chlorpheniramine Polistirex) CII Extended-Release Capsules	Bausch Health US LLC \| SpecGx LLC	2018-03-06	HUMAN PRESCRIPTION DRUG LABEL	6