Home NDC 55150-311 Hydroxyprogesterone Caproate
Product NDC 55150-311
11-digit product format 551500311
Labeler code 55150
Product ID 55150-311_b8f27635-ad16-41d2-a667-eaf51437947a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxyprogesterone Caproate
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler AuroMedics Pharma LLC
Application ANDA211142
Marketing category ANDA
Marketing start 2019-05-09
Substance HYDROXYPROGESTERONE CAPROATE
Active strength 1250 mg/5mL
Pharmacologic classes Progesterone Congeners [CS], Progestin [EPC]
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 A211142-001 HYDROXYPROGESTERONE CAPROATE HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09
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 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP2 2019-05-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP2 2019-05-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR AP2 2019-05-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211142-001 HYDROXYPROGESTERONE CAPROATE 1250MG/5ML (250MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-09 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Hydroxyprogesterone Caproate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROXYPROGESTERONE CAPROATE 1250 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 276F2O42F5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1087964 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 55150-311-01 Hydroxyprogesterone Caproate 5 mL in 1 VIAL INJECTION 5 4 55150-311-01 Hydroxyprogesterone Caproate 1 in 1 CARTON INJECTION 1 4 55150-311-05 Hydroxyprogesterone Caproate 5 in 1 CARTON INJECTION 5 4 55150-311-05 Hydroxyprogesterone Caproate 5 mL in 1 VIAL INJECTION 5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-311 HYDROXYPROGESTERONE CAPROATE INJECTION [AUROMEDICS PHARMA LLC] 4 Current NDC, Legacy NDC, 4 package rows 20220626_687bcf42-f437-42c7-8909-a91f621f55df.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.
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 55150-311-01 55150031101 1 VIAL in 1 CARTON (55150-311-01) / 5 mL in 1 VIAL 1 vial 2019-05-09 0000-00-00 No No Current 55150-311-05 55150031105 5 VIAL in 1 CARTON (55150-311-05) / 5 mL in 1 VIAL 5 vial 2019-05-09 0000-00-00 No No Current