Hydromet

Product NDC: 0472-1030
11-digit product format: 004721030
Labeler code: 0472
Product ID: 0472-1030_7937f983-1f1c-475b-ab10-76a582d1bedd
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: 2026-08-31
Substance: HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Active strength: 1.5; 5 mg/5mL; mg/5mL
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule: CII
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 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
2026-08-18 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…`
2022-09-29 23:25 UTC	2022-09	A088017-001	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	1.5MG/5ML;5MG/5ML	SYRUP / ORAL	AA	1983-07-05	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A088017-001	AA	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydromet

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCODONE BITARTRATE	1.5 mg/5mL
HOMATROPINE METHYLBROMIDE	5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NO70W886KK	Internal UNII lookup
68JRS2HC1C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992668	Internal RxNorm lookup
992675	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a324c912-a3ef-4296-b9a8-b0fec687eb06	Available on FDA.report

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	Current NDC, Legacy NDC, 1 package rows	20240616_a324c912-a3ef-4296-b9a8-b0fec687eb06.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydromet	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	Actavis Pharma, Inc.	a324c912-a3ef-4296-b9a8-b0fec687eb06	2026-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088017 application number: ANDA088017 ndc (product): 0472-1030

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	2026-08-31	No	No	Current