Buprenorphine Hydrochloride

Product NDC: 42023-179
11-digit product format: 420230179
Labeler code: 42023
Product ID: 42023-179_32a7af7e-3f90-4881-9075-473644237017
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buprenorphine Hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Par Health USA, LLC
Application: ANDA206586
Marketing category: ANDA
Marketing start: 2015-07-30
Substance: BUPRENORPHINE HYDROCHLORIDE
Active strength: .324 mg/mL
Pharmacologic classes: Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A206586-001	BUPRENORPHINE HYDROCHLORIDE	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206586-001	AP

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2015-07-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206586-001	BUPRENORPHINE HYDROCHLORIDE	EQ 0.3MG BASE/ML	INJECTABLE / INJECTION	AP		2015-07-28	`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	A206586-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206586-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206586-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206586-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206586-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206586-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206586-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206586-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206586-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206586-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206586-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206586-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206586-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206586-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206586-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206586-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206586-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206586-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206586-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206586-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206586-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206586-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206586-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206586-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206586-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206586-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206586-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206586-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206586-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206586-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206586-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206586-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206586-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206586-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206586-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206586-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206586-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206586-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206586-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206586-001	AP	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Buprenorphine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPRENORPHINE HYDROCHLORIDE	.324 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
56W8MW3EN1	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238129	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
34767dda-ce52-4f98-a45f-bb5cee0cd5e6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
68654759-f50b-79ef-24c5-544d94fe7d87	Product name	3	20251114
08a295bb-88df-4ab0-a120-a75a789a74f1	Product name	1	20231013
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
ab841ac7-728a-4fc9-be0a-35b96cecbf39	Product name	4	20230306
100316cc-94a9-474e-97ad-9b5c6ddec605	Product name	5	20230125
539bc5d3-546b-4af6-9c31-058ce6c459d3	Product name	2	20220210
b871fccd-1de6-4c7f-b9e5-045304641ee6	Product name	8	20220118
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
31e16ab2-c562-4617-a3e8-ed285320e16e	Product name	1	20180201
4c23a34c-e8fc-424c-8fa0-ee064ba6eaef	Product name	1	20170706
a5920611-4285-f024-69b9-39ff338b81ea	Product name	5	20170609
3df867ed-9d48-45cf-bded-1394beaea0b1	Product name	3	20161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4	Product name	1	20160712
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42023-179-05	Buprenorphine Hydrochloride	1 mL in 1 VIAL	INJECTION	1		22
42023-179-05	Buprenorphine Hydrochloride	5 in 1 CARTON	INJECTION	5		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42023-179-05	ML - Milliliter	42023-179	5aae02b1-485a-41d8-b4b2-e924d770210b	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Buprenorphine Hydrochloride	ACTIVE INGREDIENT	56W8MW3EN1	BUPRENORPHINE HYDROCHLORIDE INJECTION [PAR PHARMACEUTICAL INC.]	2
Buprenorphine	ACTIVE MOIETY	40D3SCR4GZ	BUPRENORPHINE HYDROCHLORIDE INJECTION [PAR PHARMACEUTICAL INC.]	2
Anhydrous Dextrose	INACTIVE INGREDIENT	5SL0G7R0OK	BUPRENORPHINE HYDROCHLORIDE INJECTION [PAR PHARMACEUTICAL INC.]	2
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	BUPRENORPHINE HYDROCHLORIDE INJECTION [PAR PHARMACEUTICAL INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	BUPRENORPHINE HYDROCHLORIDE INJECTION [PAR PHARMACEUTICAL INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42023-179	BUPRENORPHINE HYDROCHLORIDE INJECTION [ENDO USA, INC.]	11	Current NDC, Legacy NDC, 2 package rows	20240709_34767dda-ce52-4f98-a45f-bb5cee0cd5e6.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
Buprenorphine Hydrochloride	BUPRENORPHINE HYDROCHLORIDE	Par Health USA, LLC	34767dda-ce52-4f98-a45f-bb5cee0cd5e6	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206586 application number: ANDA206586 ndc (product): 42023-179

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
56W8MW3EN1	BUPRENORPHINE HYDROCHLORIDE	53152-21-9	BUPRENORPHINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238129	buprenorphine HCl 0.3 MG in 1 ML Injection	PSN	34767dda-ce52-4f98-a45f-bb5cee0cd5e6	22
238129	1 ML buprenorphine 0.3 MG/ML Injection	SCD	34767dda-ce52-4f98-a45f-bb5cee0cd5e6	22
238129	buprenorphine 0.3 MG/ML (as buprenorphine HCl 0.324 MG/ML) Injection	SY	34767dda-ce52-4f98-a45f-bb5cee0cd5e6	22
238129	buprenorphine HCl 0.3 MG per 1 ML Injection	SY	34767dda-ce52-4f98-a45f-bb5cee0cd5e6	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42023-179-05	42023017905	5 VIAL in 1 CARTON (42023-179-05) / 1 mL in 1 VIAL	5 vial	2015-07-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buprenorphine Hydrochloride Injection	Par Health USA, LLC	2025-12-18	HUMAN PRESCRIPTION DRUG LABEL	22