Buprenorphine

Product NDC: 3215-1525
11-digit product format: 032151525
Labeler code: 3215
Product ID: 3215-1525_509150ac-3394-c793-e063-6294a90ab2ee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buprenorphine
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Aveva Drug Delivery Systems Inc.
Application: ANDA210272
Marketing category: ANDA
Marketing start: 2023-11-01
Substance: BUPRENORPHINE
Active strength: 20 ug/h
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 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A210272-001	BUPRENORPHINE	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23
A210272-002	BUPRENORPHINE	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23
A210272-003	BUPRENORPHINE	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23
A210272-004	BUPRENORPHINE	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23
A210272-005	BUPRENORPHINE	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A210272-001	AB
A210272-002	AB
A210272-003	AB
A210272-004	AB
A210272-005	AB

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 5 · 165 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
2026-02-19 14:30 UTC	2026-02	A210272-001	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210272-002	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210272-003	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210272-004	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210272-005	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210272-001	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210272-002	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210272-003	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210272-004	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210272-005	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210272-001	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210272-002	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210272-003	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210272-004	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210272-005	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210272-001	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210272-002	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210272-003	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210272-004	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210272-005	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210272-001	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210272-002	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210272-003	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210272-004	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210272-005	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210272-001	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210272-002	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210272-003	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210272-004	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210272-005	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210272-001	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210272-002	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210272-003	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210272-004	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210272-005	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210272-001	BUPRENORPHINE	5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210272-002	BUPRENORPHINE	7.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210272-003	BUPRENORPHINE	10MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210272-004	BUPRENORPHINE	15MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210272-005	BUPRENORPHINE	20MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2021-09-23	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 165 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210272-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210272-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210272-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210272-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210272-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210272-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210272-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210272-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210272-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210272-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210272-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210272-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210272-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210272-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210272-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210272-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210272-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210272-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210272-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210272-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210272-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210272-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210272-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210272-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210272-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210272-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210272-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210272-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210272-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210272-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210272-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210272-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210272-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210272-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210272-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210272-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210272-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210272-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210272-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210272-005	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPRENORPHINE	20 ug/h

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
40D3SCR4GZ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
904870	Internal RxNorm lookup
904876	Internal RxNorm lookup
904880	Internal RxNorm lookup
1432969	Internal RxNorm lookup
1542997	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
1aae9b13-7431-42ef-8558-14a2325820e6	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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
3215-1525-04	Buprenorphine	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1		3
3215-1525-04	Buprenorphine	4 in 1 CARTON	PATCH, EXTENDED RELEASE	4		3

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
Buprenorphine	BUPRENORPHINE	INGENUS PHARMACEUTICALS, LLC	186e3be6-8bc0-4bb9-96f5-429d53632f45	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210272 application number: ANDA210272
Buprenorphine	BUPRENORPHINE	Aveva Drug Delivery Systems Inc.	1aae9b13-7431-42ef-8558-14a2325820e6	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210272 application number: ANDA210272 ndc (product): 3215-1525

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
40D3SCR4GZ	BUPRENORPHINE	52485-79-7	BUPRENORPHINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
904870	buprenorphine 10 MCG/HR 7 Day Transdermal System	PSN	1aae9b13-7431-42ef-8558-14a2325820e6	3
1432969	buprenorphine 15 MCG/HR 7 Day Transdermal System	PSN	1aae9b13-7431-42ef-8558-14a2325820e6	3
904876	buprenorphine 20 MCG/HR 7 Day Transdermal System	PSN	1aae9b13-7431-42ef-8558-14a2325820e6	3
904880	buprenorphine 5 MCG/HR 7 Day Transdermal System	PSN	1aae9b13-7431-42ef-8558-14a2325820e6	3
1542997	buprenorphine 7.5 MCG/HR 7 Day Transdermal System	PSN	1aae9b13-7431-42ef-8558-14a2325820e6	3
904880	168 HR buprenorphine 0.005 MG/HR Transdermal System	SCD	1aae9b13-7431-42ef-8558-14a2325820e6	3
1542997	168 HR buprenorphine 0.0075 MG/HR Transdermal System	SCD	1aae9b13-7431-42ef-8558-14a2325820e6	3
904870	168 HR buprenorphine 0.01 MG/HR Transdermal System	SCD	1aae9b13-7431-42ef-8558-14a2325820e6	3
1432969	168 HR buprenorphine 0.015 MG/HR Transdermal System	SCD	1aae9b13-7431-42ef-8558-14a2325820e6	3
904876	168 HR buprenorphine 0.02 MG/HR Transdermal System	SCD	1aae9b13-7431-42ef-8558-14a2325820e6	3
904870	buprenorphine 10 MCG/HR 7 Day Transdermal System	SY	1aae9b13-7431-42ef-8558-14a2325820e6	3
904870	buprenorphine 10 MCG/HR Weekly Transdermal Patch	SY	1aae9b13-7431-42ef-8558-14a2325820e6	3
1432969	buprenorphine 15 MCG/HR 7 Day Transdermal System	SY	1aae9b13-7431-42ef-8558-14a2325820e6	3
1432969	buprenorphine 15 MCG/HR Weekly Transdermal Patch	SY	1aae9b13-7431-42ef-8558-14a2325820e6	3
904876	buprenorphine 20 MCG/HR 7 Day Transdermal System	SY	1aae9b13-7431-42ef-8558-14a2325820e6	3
904876	buprenorphine 20 MCG/HR Weekly Transdermal Patch	SY	1aae9b13-7431-42ef-8558-14a2325820e6	3
904880	buprenorphine 5 MCG/HR 7 Day Transdermal System	SY	1aae9b13-7431-42ef-8558-14a2325820e6	3
904880	buprenorphine 5 MCG/HR Weekly Transdermal Patch	SY	1aae9b13-7431-42ef-8558-14a2325820e6	3
1542997	buprenorphine 7.5 MCG/HR 7 Day Transdermal Patch	SY	1aae9b13-7431-42ef-8558-14a2325820e6	3
1542997	buprenorphine 7.5 MCG/HR 7 Day Transdermal System	SY	1aae9b13-7431-42ef-8558-14a2325820e6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
3215-1525-04	03215152504	4 POUCH in 1 CARTON (3215-1525-04) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH	4 pouch	2023-11-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buprenorphine - Aveva Drug Delivery Systems Inc. \| DifGen Pharmaceuticals LLC	Aveva Drug Delivery Systems Inc. \| DifGen Pharmaceuticals LLC	2026-04-28	HUMAN PRESCRIPTION DRUG LABEL	3