Hydrocodone Bitartrate and Homatropine Methylbromide

Product NDC: 50383-043
11-digit product format: 503830043
Labeler code: 50383
Product ID: 50383-043_de69b3f3-56b3-4392-998c-1b0352a2fdc1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Homatropine Methylbromide
Dosage form: SOLUTION
Route: ORAL
Labeler: Akorn
Application: ANDA040613
Marketing category: ANDA
Marketing start: 2008-02-08
Marketing end: 0000-00-00
Substance: HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Active strength: 2 mg/5mL; mg/5mL
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2023-12-31
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	50383-043		I	Inactivated by FDA		2026-10-05
excluded package	package	50383-043	50383-043-16	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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-043-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-043-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-043-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-043-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-043-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-043-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-043-16	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-043-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-043-16	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-043-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-043-16	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50383-043-16	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50383-043-16	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50383-043-16	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50383-043-16	`1332a3947898…`	`d4bfe170f9cd…`

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
A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL			2008-02-08

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL			2008-02-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL			2008-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL			2008-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL			2008-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL			2008-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL			2008-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL			2008-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL			2008-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL			2008-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL			2008-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL			2008-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL			2008-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL			2008-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL			2008-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL			2008-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL			2008-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040613-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	RS	2008-02-08	`f41ea6bd6efb…`

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	A040613-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040613-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040613-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040613-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040613-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040613-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040613-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040613-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040613-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040613-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040613-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040613-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040613-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040613-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040613-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040613-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040613-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040613-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040613-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040613-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040613-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040613-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040613-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040613-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040613-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040613-001	AA	1	`cb3db0bc1861…`

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
53523715-c529-4d52-b9ff-1e5d76636f53	Product name	2	20210818
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	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
50383-043-16	2024-01-30	C162847	48780-1	1030e365-13c6-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION. HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE oral solution, CII Initial U.S. Approval: 1943

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50383-043-16	Hydrocodone Bitartrate and Homatropine Methylbromide	473 mL in 1 BOTTLE	SOLUTION	473		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-043-16	ML - Milliliter	50383-043	4f4f451e-ebcc-463f-bbde-047a12e553c7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HOMATROPINE METHYLBROMIDE	ACTIVE INGREDIENT	68JRS2HC1C	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]	9
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]	9
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]	9
METHYLHOMATROPINE	ACTIVE MOIETY	P97OGJ7L1L	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]	9
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]	9
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]	9
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]	9
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]	9
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]	9
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]	9
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]	9
SORBITOL	INACTIVE INGREDIENT	506T60A25R	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]	9
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]	9
HOMATROPINE METHYLBROMIDE	ACTIVE INGREDIENT	68JRS2HC1C	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]	3
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]	3
HOMATROPINE	ACTIVE MOIETY	8QS6WCL55Z	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]	3
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]	3
HOMATROPINE METHYLBROMIDE	ACTIVE INGREDIENT	68JRS2HC1C	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
HOMATROPINE	ACTIVE MOIETY	8QS6WCL55Z	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-043	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SOLUTION [AKORN]	21	Legacy NDC, 1 package rows	20220312_7d45e534-338b-4c98-b85f-edd19a287e14.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
992668	HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution	PSN	7d45e534-338b-4c98-b85f-edd19a287e14	21
992668	homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution	SCD	7d45e534-338b-4c98-b85f-edd19a287e14	21
992668	homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup	SY	7d45e534-338b-4c98-b85f-edd19a287e14	21
992668	HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution	PSN	0184de92-e728-4390-95f6-a463f583416a	3
992668	homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution	SCD	0184de92-e728-4390-95f6-a463f583416a	3
992668	homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup	SY	0184de92-e728-4390-95f6-a463f583416a	3
992668	HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution	PSN	0f06291e-6329-4eb0-8cb7-80a14111d480	2
992668	homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution	SCD	0f06291e-6329-4eb0-8cb7-80a14111d480	2
992668	homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup	SY	0f06291e-6329-4eb0-8cb7-80a14111d480	2
992668	HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution	PSN	95828fad-323e-4510-acbf-6d354b25b887	1
992668	homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution	SCD	95828fad-323e-4510-acbf-6d354b25b887	1
992668	homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup	SY	95828fad-323e-4510-acbf-6d354b25b887	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-043-16	50383004316	473 mL in 1 BOTTLE (50383-043-16)	473 ml	2008-02-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Homatropine Methylbromide	Akorn \| Akorn Operating Company LLC	2022-03-11	HUMAN PRESCRIPTION DRUG LABEL	21
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP	Atlantic Biologicals Corps	2016-03-01	HUMAN PRESCRIPTION DRUG LABEL	2
Hydrocodone Bitartrate and Homatropine Methylbromide Syrup	Physicians Total Care, Inc.	2011-12-15	HUMAN PRESCRIPTION DRUG LABEL	3
Hydrocodone Bitartrate and Homatropine Methylbromide Syrup	Rebel Distributors Corp	2011-01-04	HUMAN PRESCRIPTION DRUG LABEL	1