FDA.reportPublic FDA data

62991-1405

Product NDC
62991-1405
11-digit product format
629911405
Labeler code
62991
Product ID
62991-1405_025ec74e-9748-45c2-a53b-ad47b1b03206
Type
BULK INGREDIENT
Nonproprietary name
Fentanyl Citrate
Dosage form
POWDER
Marketing category
BULK INGREDIENT
Marketing start
2009-07-03
Substance
FENTANYL CITRATE
Active strength
1 g/g
DEA schedule
CII
Listing certified through
2026-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct62991-1405UNFINISHEDActive or certified unfinished drug listing2026-10-05
unfinished packagepackage62991-140562991-1405-1UNFINISHEDActive or certified unfinished drug listing2026-10-05
unfinished packagepackage62991-140562991-1405-2UNFINISHEDActive or certified unfinished drug listing2026-10-05
unfinished packagepackage62991-140562991-1405-3UNFINISHEDActive or certified unfinished drug listing2026-10-05
unfinished packagepackage62991-140562991-1405-4UNFINISHEDActive or certified unfinished drug listing2026-10-05
unfinished packagepackage62991-140562991-1405-7UNFINISHEDActive or certified unfinished drug listing2026-10-05

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 3 · 122 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage62991-1405-3a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage62991-1405-4a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage62991-1405-7a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage62991-1405-1a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage62991-1405-2a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage62991-1405-31d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage62991-1405-41d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage62991-1405-71d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage62991-1405-11d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage62991-1405-21d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage62991-1405-3390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage62991-1405-4390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage62991-1405-7390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage62991-1405-1390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage62991-1405-2390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage62991-1405-3e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage62991-1405-4e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage62991-1405-7e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage62991-1405-1e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage62991-1405-2e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage62991-1405-3bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage62991-1405-4bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage62991-1405-7bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage62991-1405-1bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage62991-1405-2bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage62991-1405-3f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage62991-1405-4f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage62991-1405-7f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage62991-1405-1f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage62991-1405-2f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage62991-1405-3f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage62991-1405-4f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage62991-1405-7f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage62991-1405-1f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage62991-1405-2f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage62991-1405-368b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage62991-1405-468b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage62991-1405-768b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage62991-1405-168b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage62991-1405-268b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage62991-1405-305c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage62991-1405-405c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage62991-1405-705c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage62991-1405-105c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage62991-1405-205c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage62991-1405-348b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage62991-1405-448b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage62991-1405-748b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage62991-1405-148b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage62991-1405-248b4f40e6753…c7c7a00d2afa…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENTANYL CITRATE1 g/g

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62991-1405-1GM - Gram62991-1405a14fe323-b9d2-49f6-8389-e18d655160dd12013-02-19
62991-1405-2GM - Gram62991-1405fac9a96a-e876-4f44-8448-2b300069568a12013-02-19
62991-1405-3GM - Gram62991-14058534e9d9-2d13-43b3-a22f-63831cdf4d2312013-02-19
62991-1405-4GM - Gram62991-1405a521de05-3a9d-4601-a767-e4423ac5f08e12013-02-19
62991-1405-6GM - Gram62991-14059a4f2e90-115b-43f7-be49-e84bebf80f2112013-02-19
62991-1405-7GM - Gram62991-14057bfa0c0d-3e66-4bd8-b86f-c5eb8871df1e12014-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
62991-1405-162991140501.1 g in 1 JAR (62991-1405-1)03-JUL-09Current
62991-1405-262991140502.5 g in 1 JAR (62991-1405-2)03-JUL-09Current
62991-1405-3629911405031 g in 1 JAR (62991-1405-3)1 g03-JUL-09Current
62991-1405-4629911405045 g in 1 JAR (62991-1405-4)5 g03-JUL-09Current
62991-1405-76299114050725 g in 1 JAR (62991-1405-7)25 g03-JUL-09Current