Hycodan

Product NDC: 64950-342
11-digit product format: 649500342
Labeler code: 64950
Product ID: 64950-342_c1633e0f-dae2-4bd4-ac4d-de8498ee9398
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Homatropine Methylbromide
Dosage form: SOLUTION
Route: ORAL
Labeler: Genus Lifesciences Inc.
Application: NDA005213
Marketing category: NDA
Marketing start: 2019-06-10
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]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64950-342		D	Discontinued by firm	2026-08-11
excluded package	package	64950-342	64950-342-45	D	Discontinued by firm	2026-08-11
excluded package	package	64950-342	64950-342-47	D	Discontinued by firm	2026-08-11

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
N005213-001	HYCODAN	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26
N005213-002	HYCODAN	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N005213-001	AA
N005213-002	AA

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N005213-001	HYCODAN	1.5MG;5MG	TABLET / ORAL	AA	RLD	1988-07-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RLD	1988-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N005213-001	HYCODAN	1.5MG;5MG	TABLET / ORAL	AA	RLD	1988-07-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RLD	1988-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1988-07-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	AA	RLD	1988-07-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N005213-001	HYCODAN	1.5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	AA	RLD	1988-07-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N005213-002	HYCODAN	1.5MG/5ML;5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	AA	RLD	1988-07-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N005213-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N005213-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N005213-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N005213-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N005213-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N005213-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N005213-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N005213-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005213-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N005213-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005213-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N005213-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N005213-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N005213-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N005213-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N005213-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N005213-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N005213-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N005213-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N005213-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N005213-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N005213-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N005213-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N005213-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N005213-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N005213-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N005213-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N005213-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N005213-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N005213-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N005213-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N005213-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N005213-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N005213-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N005213-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N005213-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N005213-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N005213-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N005213-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N005213-002	AA	1	`87673890dc5c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64950-342-05	ML - Milliliter	64950-342	d1e8b901-1786-499e-a4af-c6a09bf1db1a	1	2021-08-05
64950-342-45	ML - Milliliter	64950-342	8ee929d6-91dc-49e3-95f1-7f4e7e16d039	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64950-342	HYCODAN (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) TABLET HYCODAN (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SOLUTION [GENUS LIFESCIENCES INC.]	7	Legacy NDC	20250509_901d4115-f71a-4681-bd0e-c9b691151b78.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocodone Bitartrate and Homatropine Methylbromide	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	Genus Lifesciences Inc.	320ff639-9854-407b-9bbd-a035c4f173e1	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 005213 application number: NDA005213
Hydrocodone Bitartrate and Homatropine Methylbromide	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	PAI Holdings, LLC dba PAI Pharma	71319a6f-aaf4-4bc5-8b40-a16c6f139be6	2026-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 005213 application number: NDA005213

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NO70W886KK	HYDROCODONE BITARTRATE	34195-34-1	HYDROCODONE BITARTRATE
68JRS2HC1C	HOMATROPINE METHYLBROMIDE	80-49-9	HOMATROPINE METHYLBROMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64950-342-45	64950034245	40 CUP, UNIT-DOSE in 1 CASE (64950-342-45) > 5 mL in 1 CUP, UNIT-DOSE (64950-342-05)		2019-12-16	0000-00-00	No	No	Current
64950-342-47	64950034247	473 mL in 1 BOTTLE (64950-342-47)	473 ml	2019-06-14	0000-00-00	No	No	Current