AVC

Product NDC
0037-6631
11-digit product format
000376631
Labeler code
0037
Product ID
0037-6631_cb8394e1-a813-45f5-b358-3e69d2196fe9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfanilamide
Dosage form
CREAM
Route
VAGINAL
Labeler
Meda Pharmaceuticals
Application
NDA006530
Marketing category
NDA
Marketing start
2014-12-01
Marketing end
0000-00-00
Substance
SULFANILAMIDE
Active strength
15 g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0037-6631DDiscontinued by firm2026-08-03
excluded packagepackage0037-66310037-6631-04DDiscontinued by firm2026-08-03

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 · 24 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 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0037-6631-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0037-6631-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0037-6631-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0037-6631-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0037-6631-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0037-6631-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0037-6631-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0037-6631-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0037-6631-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0037-6631-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0037-6631-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0037-6631-04557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N006530-003AVCSULFANILAMIDE15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / VAGINALRLD1987-01-27
N006530-004AVCSULFANILAMIDE1.05GMSUPPOSITORY / VAGINAL1987-01-27

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N006530-003AVC15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / VAGINALRLD1987-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006530-003AVC15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / VAGINALRLD1987-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N006530-003AVC15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / VAGINALRLD1987-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006530-003AVC15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / VAGINALRLD1987-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N006530-003AVC15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / VAGINALRLD1987-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N006530-003AVC15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / VAGINALRLD1987-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N006530-003AVC15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / VAGINALRLD1987-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N006530-003AVC15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / VAGINALRLD1987-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N006530-003AVC15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / VAGINALRLD1987-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N006530-003AVC15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / VAGINALRLD1987-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N006530-003AVC15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / VAGINALRLD1987-01-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N006530-003AVC15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / VAGINALRLD1987-01-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N006530-003AVC15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / VAGINALRLD1987-01-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N006530-003AVC15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / VAGINALRLD1987-01-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N006530-003AVC15%CREAM / VAGINALRLD1987-01-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N006530-003AVC15%CREAM / VAGINALRLD1987-01-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N006530-003AVC15%CREAM / VAGINALRLD1987-01-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N006530-003AVC15%CREAM / VAGINALRLD, RS1987-01-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N006530-003AVC15%CREAM / VAGINALRLD1987-01-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N006530-003AVC15%CREAM / VAGINALRLD1987-01-27782e0a99824c…
2021-12-28 21:50 UTC2021-12N006530-004AVC1.05GMSUPPOSITORY / VAGINAL1987-01-27782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0037-6631-04GM - Gram0037-6631b5b3179a-f1c1-4c91-b5c2-879630f01f7812015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFANILAMIDEACTIVE INGREDIENT21240MF57MAVC (SULFANILAMIDE) CREAM [MEDA PHARMACEUTICALS]1
SULFANILAMIDEACTIVE MOIETY21240MF57MAVC (SULFANILAMIDE) CREAM [MEDA PHARMACEUTICALS]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATAVC (SULFANILAMIDE) CREAM [MEDA PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAVC (SULFANILAMIDE) CREAM [MEDA PHARMACEUTICALS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAVC (SULFANILAMIDE) CREAM [MEDA PHARMACEUTICALS]1
PEG-2 STEARATEINACTIVE INGREDIENT94YQ11Y95FAVC (SULFANILAMIDE) CREAM [MEDA PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AVC (SULFANILAMIDE) CREAM [MEDA PHARMACEUTICALS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAVC (SULFANILAMIDE) CREAM [MEDA PHARMACEUTICALS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAVC (SULFANILAMIDE) CREAM [MEDA PHARMACEUTICALS]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKAVC (SULFANILAMIDE) CREAM [MEDA PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RAVC (SULFANILAMIDE) CREAM [MEDA PHARMACEUTICALS]1