Hydromet

Product NDC: 0472-1030
11-digit product format: 004721030
Labeler code: 0472
Product ID: 0472-1030_13833a04-8f2d-4ac7-bc72-b661457fec56
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydrocodone bitartrate and homatropine methylbromide
Dosage form: SOLUTION
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA088017
Marketing category: ANDA
Marketing start: 2002-09-30
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	0472-1030		D	Discontinued by firm		2026-10-05
excluded package	package	0472-1030	0472-1030-16	D	Discontinued by firm		2026-10-05

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
A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA		1983-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088017-001	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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A088017-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088017-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088017-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088017-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088017-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088017-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088017-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088017-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088017-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088017-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088017-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088017-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088017-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088017-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088017-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088017-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088017-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088017-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088017-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088017-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088017-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088017-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088017-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088017-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088017-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088017-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088017-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088017-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088017-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088017-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088017-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088017-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088017-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088017-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088017-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088017-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088017-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088017-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088017-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088017-001	AA	1	`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
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0472-1030-16	Hydromet	473 mL in 1 BOTTLE	SOLUTION	473		28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0472-1030-16	ML - Milliliter	0472-1030	1cf434c7-ea5b-48ff-99c3-e243c67fbf0e	1	2013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HOMATROPINE METHYLBROMIDE	ACTIVE INGREDIENT	68JRS2HC1C	HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]	7
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]	7
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]	7
METHYLHOMATROPINE	ACTIVE MOIETY	P97OGJ7L1L	HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]	7
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]	7
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]	7
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]	7
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]	7
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]	7
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]	7
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]	7
SUCROSE	INACTIVE INGREDIENT	C151H8M554	HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SYRUP [ACTAVIS MID ATLANTIC LLC]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0472-1030	HYDROMET (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SOLUTION [ACTAVIS PHARMA, INC.]	26	Legacy NDC, 1 package rows	20240616_a324c912-a3ef-4296-b9a8-b0fec687eb06.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	a324c912-a3ef-4296-b9a8-b0fec687eb06	28
992675	Hydromet 5 MG / 1.5 MG in 5 mL Oral Solution	PSN	a324c912-a3ef-4296-b9a8-b0fec687eb06	28
992675	homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution [Hydromet]	SBD	a324c912-a3ef-4296-b9a8-b0fec687eb06	28
992668	homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution	SCD	a324c912-a3ef-4296-b9a8-b0fec687eb06	28
992668	homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup	SY	a324c912-a3ef-4296-b9a8-b0fec687eb06	28
992675	Hydromet (homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG) per 5 ML Syrup	SY	a324c912-a3ef-4296-b9a8-b0fec687eb06	28

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0472-1030-16	00472103016	473 mL in 1 BOTTLE (0472-1030-16)	473 ml	2002-09-30	0000-00-00	No	No	Current