Home NDC 51672-4117-9 Nystatin
Product NDC 51672-4117
Requested package NDC 51672-4117-9
11-digit product format 516724117
Labeler code 51672
Product ID 51672-4117_29a58f9e-6262-8297-e063-6294a90ad86d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form SUSPENSION
Route ORAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA062876
Marketing category ANDA
Marketing start 1988-02-29
Substance NYSTATIN
Active strength 100000 [USP'U]/mL
Pharmacologic classes Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A062876-001 NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1988-02-29
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 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1988-02-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1988-02-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1988-02-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062876-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1988-02-29 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-4117-0 Nystatin 3785 mL in 1 BOTTLE SUSPENSION 3785 5 51672-4117-4 Nystatin 1 in 1 CARTON SUSPENSION 1 5 51672-4117-4 Nystatin 60 mL in 1 BOTTLE, DROPPER SUSPENSION 60 5 51672-4117-9 Nystatin 473 mL in 1 BOTTLE SUSPENSION 473 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 alcohol INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 benzaldehyde INACTIVE INGREDIENT TA269SD04T NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 edetate calcium disodium INACTIVE INGREDIENT 25IH6R4SGF NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 magnesium aluminum silicate INACTIVE INGREDIENT 6M3P64V0NC NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 sucrose INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2 xanthan gum INACTIVE INGREDIENT TTV12P4NEE NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4117 NYSTATIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 5 Current NDC, Legacy NDC, 4 package rows 20241222_01c469b3-ec10-452c-8c02-3e7d22e40297.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-4117-9 51672411709 473 mL in 1 BOTTLE (51672-4117-9) 473 ml 1988-02-29 0000-00-00 No No Current