Nystatin

Product NDC
13668-595
11-digit product format
136680595
Labeler code
13668
Product ID
13668-595_96bcc133-c446-4fce-a99a-ccd1039ded49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nystatin
Dosage form
CREAM
Route
TOPICAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA212557
Marketing category
ANDA
Marketing start
2019-07-24
Substance
NYSTATIN
Active strength
100000 U/g
Pharmacologic classes
Polyene Antifungal [EPC], Polyenes [CS]
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212557-001NYSTATINNYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212557-001AT

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-243f01610625f2…
2019-09-15 20:21 UTC2019-09A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212557-001NYSTATIN100,000 UNITS/GMCREAM / TOPICALAT2019-07-24cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A212557-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212557-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212557-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212557-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212557-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212557-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212557-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212557-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212557-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212557-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212557-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212557-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212557-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212557-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212557-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212557-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212557-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212557-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212557-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212557-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212557-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212557-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A212557-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212557-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212557-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A212557-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A212557-001AT1b00525d2431f…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212557-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212557-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212557-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212557-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212557-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212557-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212557-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A212557-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A212557-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212557-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212557-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212557-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212557-001AT1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NYSTATIN100000 U/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BDF1O1C72EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
543546Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
559b5bd4-3564-4437-8d0a-fa3a972f8b83Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e29fe634-dc25-094c-c77f-5d09c3eceb3eProduct name520260107
e57b6340-9387-3f9a-7307-511c81791375Product name320221214
544f8e8d-6389-eeeb-9586-aa447c08dcc7Product name520210614
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
854ec07b-1cd7-a5db-235a-7aa24d3cf97aProduct name320180628
19b9f4c1-15e9-edcc-4c16-f01ecfb5c549Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-595-01Nystatin15 g in 1 TUBECREAM159
13668-595-02Nystatin30 g in 1 TUBECREAM309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-595-01GM - Gram13668-59508636fea-4fd2-4c71-8506-c87246ff959712020-09-14
13668-595-02GM - Gram13668-595442c4624-77ec-4adb-ab69-9c31f900e7d812020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-595NYSTATIN CREAM [TORRENT PHARMACEUTICALS LIMITED]8Current NDC, Legacy NDC, 2 package rows20250206_559b5bd4-3564-4437-8d0a-fa3a972f8b83.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NystatinNYSTATINPreferred Pharmaceuticals Inc.d92f67a7-dcae-41c0-9a35-dbafa23611702026-08-04Adverse reactionsExact identifier
application applno (ANDA): 212557
application number: ANDA212557
NystatinNYSTATINBryant Ranch Prepack2d2c4f79-95b5-417e-b5c1-8fac1dd09ddc2026-07-09Adverse reactionsExact identifier
application applno (ANDA): 212557
application number: ANDA212557
NystatinNYSTATINTorrent Pharmaceuticals Limited559b5bd4-3564-4437-8d0a-fa3a972f8b832026-05-01Adverse reactionsExact identifier
application applno (ANDA): 212557
application number: ANDA212557
ndc (product): 13668-595
NystatinNYSTATINRedPharm Drug, Incf4c298d5-b012-7b56-e053-2a95a90a3d552026-01-24Adverse reactionsExact identifier
application applno (ANDA): 212557
application number: ANDA212557
NystatinNYSTATINA-S Medication Solutions65167baa-29f8-44d3-b2d2-935c862d463e2024-10-16Adverse reactionsExact identifier
application applno (ANDA): 212557
application number: ANDA212557
NystatinNYSTATINProficient Rx LP8566c432-741f-4af7-91d7-1b7668ce5e952023-12-01Adverse reactionsExact identifier
application applno (ANDA): 212557
application number: ANDA212557

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543546nystatin 100,000 UNT/GM Topical CreamPSN2d2c4f79-95b5-417e-b5c1-8fac1dd09ddc100
543546nystatin 100000 UNT/ML Topical CreamSCD2d2c4f79-95b5-417e-b5c1-8fac1dd09ddc100
543546nystatin 100,000 UNT/GM Topical CreamSY2d2c4f79-95b5-417e-b5c1-8fac1dd09ddc100
543546nystatin 100,000 UNT/GM Topical CreamPSN559b5bd4-3564-4437-8d0a-fa3a972f8b839
543546nystatin 100000 UNT/ML Topical CreamSCD559b5bd4-3564-4437-8d0a-fa3a972f8b839
543546nystatin 100,000 UNT/GM Topical CreamSY559b5bd4-3564-4437-8d0a-fa3a972f8b839
543546nystatin 100,000 UNT/GM Topical CreamPSNf4c298d5-b012-7b56-e053-2a95a90a3d554
543546nystatin 100000 UNT/ML Topical CreamSCDf4c298d5-b012-7b56-e053-2a95a90a3d554
543546nystatin 100,000 UNT/GM Topical CreamSYf4c298d5-b012-7b56-e053-2a95a90a3d554
543546nystatin 100,000 UNT/GM Topical CreamPSNd92f67a7-dcae-41c0-9a35-dbafa23611702
543546nystatin 100000 UNT/ML Topical CreamSCDd92f67a7-dcae-41c0-9a35-dbafa23611702
543546nystatin 100,000 UNT/GM Topical CreamSYd92f67a7-dcae-41c0-9a35-dbafa23611702
543546nystatin 100,000 UNT/GM Topical CreamPSN8566c432-741f-4af7-91d7-1b7668ce5e951
543546nystatin 100,000 UNT/GM Topical CreamPSNe70108bd-ddcf-04f6-e053-2a95a90a01c01
543546nystatin 100,000 UNT/GM Topical CreamPSNee16e52c-ebb0-3330-e053-2995a90af2e81
543546nystatin 100,000 UNT/GM Topical CreamPSN65167baa-29f8-44d3-b2d2-935c862d463e1
543546nystatin 100000 UNT/ML Topical CreamSCD8566c432-741f-4af7-91d7-1b7668ce5e951
543546nystatin 100000 UNT/ML Topical CreamSCDe70108bd-ddcf-04f6-e053-2a95a90a01c01
543546nystatin 100000 UNT/ML Topical CreamSCDee16e52c-ebb0-3330-e053-2995a90af2e81
543546nystatin 100000 UNT/ML Topical CreamSCD65167baa-29f8-44d3-b2d2-935c862d463e1
543546nystatin 100,000 UNT/GM Topical CreamSY8566c432-741f-4af7-91d7-1b7668ce5e951
543546nystatin 100,000 UNT/GM Topical CreamSYe70108bd-ddcf-04f6-e053-2a95a90a01c01
543546nystatin 100,000 UNT/GM Topical CreamSYee16e52c-ebb0-3330-e053-2995a90af2e81
543546nystatin 100,000 UNT/GM Topical CreamSY65167baa-29f8-44d3-b2d2-935c862d463e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-595-011366805950115 g in 1 TUBE (13668-595-01) 15 g2019-07-240000-00-00NoNoCurrent
13668-595-021366805950230 g in 1 TUBE (13668-595-02) 30 g2019-07-240000-00-00NoNoCurrent