38779-0888-0

Product NDC: 38779-0888
Requested package NDC: 38779-0888-0
11-digit product format: 387790888
Labeler code: 38779
Product ID: 38779-0888_4aa7e559-c855-b495-e063-6394a90a3366
Type: BULK INGREDIENT
Nonproprietary name: Buprenorphine Hydrochloride
Dosage form: POWDER
Marketing category: BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Marketing start: 2014-07-28
Substance: BUPRENORPHINE HYDROCHLORIDE
Active strength: 1 g/g
DEA schedule: CIII
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	38779-0888	38779-0888-0	UNFINISHED	Active or certified unfinished drug listing		2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: No
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPRENORPHINE HYDROCHLORIDE	1 g/g

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
38779-0888-0	GM - Gram	38779-0888	ea475beb-91f1-4bce-ba3e-3ec1b988f3f9	1	2014-09-03
38779-0888-1	GM - Gram	38779-0888	3fd81d18-9e25-45de-8c87-ee5e50fce5a8	1	2014-09-03
38779-0888-3	GM - Gram	38779-0888	42cd3e9d-3565-4121-972d-4b8020e22216	1	2014-09-03
38779-0888-6	GM - Gram	38779-0888	356a495c-16ae-4ea4-8c6c-20d53148d9b4	1	2014-09-03
38779-0888-9	GM - Gram	38779-0888	5b7015c7-96d3-4be2-bb53-082d7a263986	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPRENORPHINE HYDROCHLORIDE	ACTIVE INGREDIENT	56W8MW3EN1	BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]	1
BUPRENORPHINE	ACTIVE MOIETY	40D3SCR4GZ	BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]	1

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	a1c1f498-e101-467f-b81c-1451c44e7a01	10
238129	1 ML buprenorphine 0.3 MG/ML Injection	SCD	a1c1f498-e101-467f-b81c-1451c44e7a01	10
238129	buprenorphine 0.3 MG/ML (as buprenorphine HCl 0.324 MG/ML) Injection	SY	a1c1f498-e101-467f-b81c-1451c44e7a01	10
238129	buprenorphine HCl 0.3 MG per 1 ML Injection	SY	a1c1f498-e101-467f-b81c-1451c44e7a01	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
38779-0888-0	38779088800	.5 g in 1 BOTTLE, GLASS (38779-0888-0)	28-JUL-14	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
buprenorphine - PAYLESS COMPOUNDERS, LLC	PAYLESS COMPOUNDERS, LLC	2024-12-11	ANIMAL COMPOUNDED DRUG LABEL	10