Hydrocodone Bitartrate and Homatropine Methylbromide

Product NDC: 43386-118
11-digit product format: 433860118
Labeler code: 43386
Product ID: 43386-118_116df522-26b7-42de-8c0b-16cc60c2e764
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrocodone Bitartrate and Homatropine Methylbromide
Dosage form: TABLET
Route: ORAL
Labeler: Lupin Pharmaceuticals,Inc.
Application: ANDA091528
Marketing category: ANDA
Marketing start: 2014-09-23
Substance: HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Active strength: 1.5; 5 mg/1; mg/1
Pharmacologic classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

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
A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20

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 · 41 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	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL	AA	RS	2011-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL	AA	RS	2011-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL	AA	RS	2011-04-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL	AA		2011-04-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL	AA	RS	2011-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL	AA	RS	2011-04-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL	AA	RS	2011-04-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL	AA	RS	2011-04-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL	AA	RS	2011-04-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL	AA	RS	2011-04-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL	AA		2011-04-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL	AA		2011-04-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL	AA		2011-04-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL			2011-04-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL	AA	RS	2011-04-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL	AA	RS	2011-04-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL	AA	RS	2011-04-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091528-001	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	1.5MG;5MG	TABLET / ORAL	AA	RS	2011-04-20	`cb3db0bc1861…`

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	A091528-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091528-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091528-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091528-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091528-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091528-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091528-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091528-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091528-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091528-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091528-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091528-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091528-001	AA	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091528-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091528-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091528-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091528-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydrocodone Bitartrate and Homatropine Methylbromide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCODONE BITARTRATE	1.5 mg/1
HOMATROPINE METHYLBROMIDE	5 mg/1

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992656	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
41ac90b3-f007-4eb2-9d41-ea626ced2017	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	SPL version
43386-118-01	Hydrocodone Bitartrate and Homatropine Methylbromide	100 in 1 BOTTLE	TABLET	100	6
43386-118-03	Hydrocodone Bitartrate and Homatropine Methylbromide	30 in 1 BOTTLE	TABLET	30	6
43386-118-05	Hydrocodone Bitartrate and Homatropine Methylbromide	500 in 1 BOTTLE	TABLET	500	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43386-118-01	EA - Each	43386-118	923e9d9e-4167-4849-bfd1-3f8b79063be3	1	2014-10-03
43386-118-03	EA - Each	43386-118	cd2f155f-accd-45da-be19-225e21d5fd3c	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HOMATROPINE METHYLBROMIDE	ACTIVE INGREDIENT	68JRS2HC1C	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	1
HYDROCODONE BITARTRATE	ACTIVE INGREDIENT	NO70W886KK	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	1
HYDROCODONE	ACTIVE MOIETY	6YKS4Y3WQ7	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	1
METHYLHOMATROPINE	ACTIVE MOIETY	P97OGJ7L1L	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [GAVIS PHARMACEUTICALS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-118	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [LUPIN PHARMACEUTICALS,INC.]	6	Current NDC, Legacy NDC, 3 package rows	20241204_41ac90b3-f007-4eb2-9d41-ea626ced2017.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	Lupin Pharmaceuticals,Inc.	41ac90b3-f007-4eb2-9d41-ea626ced2017	2024-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091528 application number: ANDA091528 ndc (product): 43386-118
Hydrocodone Bitartrate and Homatropine Methylbromide	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	Novel Laboratories, Inc.	b203c87c-1108-4eaa-8a57-87be776d8a70	2023-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091528 application number: ANDA091528

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
992656	HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG Oral Tablet	PSN	41ac90b3-f007-4eb2-9d41-ea626ced2017	6
992656	homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG Oral Tablet	SCD	41ac90b3-f007-4eb2-9d41-ea626ced2017	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43386-118-01	43386011801	100 TABLET in 1 BOTTLE (43386-118-01)	100 tablet	2014-09-23	0000-00-00	Yes	No	Current
43386-118-03	43386011803	30 TABLET in 1 BOTTLE (43386-118-03)	30 tablet	2014-09-23	0000-00-00	Yes	No	Current
43386-118-05	43386011805	500 TABLET in 1 BOTTLE (43386-118-05)	500 tablet	2014-09-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrocodone Bitartrate and Homatropine Methylbromide	Lupin Pharmaceuticals,Inc. \| Novel Laboratories, Inc.	2024-09-12	HUMAN PRESCRIPTION DRUG LABEL	6