Home NDC 0143-9742 Oxytocin
Product NDC 0143-9742
11-digit product format 001439742
Labeler code 0143
Product ID 0143-9742_9a99920c-c630-487a-a1fc-5289eeaf451b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxytocin
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler West-Ward Pharmaceuticals Corp
Application ANDA200219
Marketing category ANDA
Marketing start 2013-02-13
Substance OXYTOCIN
Active strength 10 [USP'U]/mL
Pharmacologic classes Increased Uterine Smooth Muscle Contraction or Tone [PE], Oxytocic [EPC], Oxytocin [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 A200219-001 OXYTOCIN OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200219-001 AP
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 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200219-001 OXYTOCIN 10USP UNITS/ML (10USP UNITS/ML) INJECTABLE / INJECTION AP 2013-02-13 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Oxytocin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYTOCIN 10 [USP'U]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1JQS135EYN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238013 Internal RxNorm lookup 1791721 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0143-9742-01 Oxytocin 10 mL in 1 VIAL INJECTION 10 2 0143-9742-25 Oxytocin 25 in 1 CARTON INJECTION 25 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9742 OXYTOCIN INJECTION [WEST-WARD PHARMACEUTICALS CORP] 2 Current NDC, Legacy NDC, 2 package rows 20181215_d16a48c5-6b71-40a0-bcda-204f043fe832.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Oxytocin OXYTOCIN West-Ward Pharmaceuticals Corp d16a48c5-6b71-40a0-bcda-204f043fe832 2018-12-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200219 application number: ANDA200219 ndc (product): 0143-9742
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 0143-9742-01 00143974201 10 mL in 1 VIAL 10 ml Historical 0143-9742-25 00143974225 25 VIAL in 1 CARTON (0143-9742-25) / 10 mL in 1 VIAL (0143-9742-01) 25 vial 2013-02-13 0000-00-00 No No Current