Medroxyprogesterone Acetate

Product NDC
0555-0779
11-digit product format
005550779
Labeler code
0555
Product ID
0555-0779_b8f519a9-a8d0-4dd5-b138-564fb579c461
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA040159
Marketing category
ANDA
Marketing start
1996-12-04
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
10 mg/1
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040159-001MEDROXYPROGESTERONE ACETATEMEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-09
A040159-002MEDROXYPROGESTERONE ACETATEMEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-09
A040159-003MEDROXYPROGESTERONE ACETATEMEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A040159-001AB
A040159-002AB
A040159-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-09caaa826d4ba7…
2026-08-18 06:07:402026-07A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-09caaa826d4ba7…
2026-08-18 06:07:402026-07A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040159-002MEDROXYPROGESTERONE ACETATE5MGTABLET / ORALAB1996-08-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040159-003MEDROXYPROGESTERONE ACETATE10MGTABLET / ORALAB1996-08-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040159-001MEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALAB1996-08-091e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040159-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040159-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040159-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040159-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040159-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040159-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040159-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040159-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040159-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040159-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040159-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040159-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040159-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040159-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040159-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040159-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040159-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040159-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040159-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040159-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040159-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040159-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040159-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040159-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040159-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040159-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040159-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040159-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040159-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040159-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040159-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040159-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040159-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040159-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040159-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040159-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040159-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040159-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040159-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040159-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Medroxyprogesterone Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEDROXYPROGESTERONE ACETATE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C2QI4IOI2GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000114Internal RxNorm lookup
1000135Internal RxNorm lookup
1000141Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9eb200b0-db96-4a51-87ea-04db862978c8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dceProduct name620240606
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2Product name120140508
51a98800-9a04-9e42-2219-e588f17f9e48Product name120140508
f363ed61-d8ad-8f59-ee92-52a12578e008Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-0779-02Medroxyprogesterone Acetate100 in 1 BOTTLETABLET10017
0555-0779-04Medroxyprogesterone Acetate500 in 1 BOTTLETABLET50017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0779-02EA - Each0555-07794b790d66-793c-4b5a-97ab-356f53249e1212013-02-13
0555-0779-04EA - Each0555-07795aed0975-064d-4581-9ec0-81fc32c910a612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1001
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1001
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1001
METHYLCELLULOSE (15 CPS)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1001
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1001
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1001
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1000
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1000
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1000
METHYLCELLULOSE (15 CPS)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1000
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1000
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [READYMEDS]8
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [BARR LABORATORIES INC.]8
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [READYMEDS]8
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [BARR LABORATORIES INC.]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [READYMEDS]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [BARR LABORATORIES INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [READYMEDS]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [BARR LABORATORIES INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [READYMEDS]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [BARR LABORATORIES INC.]8
METHYLCELLULOSE (15 MPA.S)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [READYMEDS]8
METHYLCELLULOSE (15 MPA.S)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [BARR LABORATORIES INC.]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [READYMEDS]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [BARR LABORATORIES INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [BARR LABORATORIES INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [READYMEDS]8
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.]3
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.]3
METHYLCELLULOSE (15 MPA.S)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.]3
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [REBEL DISTRIBUTORS CORP.]2
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]2
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]2
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [REBEL DISTRIBUTORS CORP.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [REBEL DISTRIBUTORS CORP.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [REBEL DISTRIBUTORS CORP.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [REBEL DISTRIBUTORS CORP.]2
METHYLCELLULOSE (15 CPS)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]2
METHYLCELLULOSE (15 CPS)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [REBEL DISTRIBUTORS CORP.]2
METHYLCELLULOSE (15 MPA.S)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [REBEL DISTRIBUTORS CORP.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [REBEL DISTRIBUTORS CORP.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [PREFERRED PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]2
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]1
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
METHYLCELLULOSE (15 MPA.S)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
METHYLCELLULOSE (15 MPA.S)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-0779MEDROXYPROGESTERONE ACETATE TABLET [TEVA PHARMACEUTICALS USA, INC.]17Current NDC, Legacy NDC, 2 package rows20240620_9eb200b0-db96-4a51-87ea-04db862978c8.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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEREMEDYREPACK INC.e3dfd683-d44e-427b-af06-70b9b698e0162026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEPreferred Pharmaceuticals Inc.a9e05272-aa4e-4df8-b08b-481abca3e8fd2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEPreferred Pharmaceuticals, Inc.37275fd0-eb24-40a4-a93f-b818bb98414e2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEREMEDYREPACK INC.1020bb60-4f13-4cd7-aaa1-c556752c84b72026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutions816b9fd2-bc55-496b-846a-cabe7bbdecd62026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATENorthwind Health Company, LLC0de6142f-a78e-ae58-e063-6394a90adff02026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEAmerican Health Packagingcbf142f9-9af3-4d79-9343-0ab42d6dbe9f2025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEPD-Rx Pharmaceuticals, Inc.6a541749-5d14-44aa-a409-5e51f5bbf9292025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutionsbfdf335d-1cbb-4533-9fde-99a9c71f75042025-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutions788df737-e990-4b5e-accd-af13c3b2bf8b2025-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATECoupler LLC2cf48919-6de8-d3d0-e063-6394a90ac1bc2025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEPD-Rx Pharmaceuticals, Inc.437edd12-2c08-4df4-8cf7-64c47e4779ac2025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEBryant Ranch Prepacka36c89b7-9463-4d00-a4d3-021d770900772024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEBryant Ranch Prepacka88b33ff-842b-4a5b-a27e-9c2b9e85a4d72024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEBryant Ranch Prepackbdb89690-ced2-48e1-bb1a-e5eccfeda8eb2024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEBryant Ranch Prepackd9ad130b-8f9a-4a0f-beb4-b692b6d3c5ca2024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATENuCare Pharmaceuticals,Inc.5c8ffae3-3b3e-197e-e053-2a91aa0a59e32024-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATETeva Pharmaceuticals USA, Inc.9eb200b0-db96-4a51-87ea-04db862978c82024-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
ndc (product): 0555-0779
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEProficient Rx LP0df6fd1e-7d9c-4a38-848c-1e562e211c912023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159
MedroxyprogesteroneMEDROXYPROGESTERONEPharmPak, Inc.1403a9a9-c04a-432f-8819-4850f779312e2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040159
application number: ANDA040159

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSNbdb89690-ced2-48e1-bb1a-e5eccfeda8eb1012
1000114medroxyprogesterone acetate 10 MG Oral TabletSCDbdb89690-ced2-48e1-bb1a-e5eccfeda8eb1012
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSNa36c89b7-9463-4d00-a4d3-021d77090077103
1000114medroxyprogesterone acetate 10 MG Oral TabletSCDa36c89b7-9463-4d00-a4d3-021d77090077103
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN437edd12-2c08-4df4-8cf7-64c47e4779ac24
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD437edd12-2c08-4df4-8cf7-64c47e4779ac24
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN816b9fd2-bc55-496b-846a-cabe7bbdecd617
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN9eb200b0-db96-4a51-87ea-04db862978c817
1000135medroxyPROGESTERone acetate 2.5 MG Oral TabletPSN9eb200b0-db96-4a51-87ea-04db862978c817
1000141medroxyPROGESTERone acetate 5 MG Oral TabletPSN9eb200b0-db96-4a51-87ea-04db862978c817
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD9eb200b0-db96-4a51-87ea-04db862978c817
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD816b9fd2-bc55-496b-846a-cabe7bbdecd617
1000135medroxyprogesterone acetate 2.5 MG Oral TabletSCD9eb200b0-db96-4a51-87ea-04db862978c817
1000141medroxyprogesterone acetate 5 MG Oral TabletSCD9eb200b0-db96-4a51-87ea-04db862978c817
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN37275fd0-eb24-40a4-a93f-b818bb98414e11
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD37275fd0-eb24-40a4-a93f-b818bb98414e11
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSNec517411-6d3d-4cb1-a50e-f0818d03b0e48
1000135medroxyPROGESTERone acetate 2.5 MG Oral TabletPSNec517411-6d3d-4cb1-a50e-f0818d03b0e48
1000114medroxyprogesterone acetate 10 MG Oral TabletSCDec517411-6d3d-4cb1-a50e-f0818d03b0e48
1000135medroxyprogesterone acetate 2.5 MG Oral TabletSCDec517411-6d3d-4cb1-a50e-f0818d03b0e48
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSNcbf142f9-9af3-4d79-9343-0ab42d6dbe9f6
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSNceccfb43-ad89-482d-9564-5867df1c936f6
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN5c8ffae3-3b3e-197e-e053-2a91aa0a59e36
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD5c8ffae3-3b3e-197e-e053-2a91aa0a59e36
1000114medroxyprogesterone acetate 10 MG Oral TabletSCDceccfb43-ad89-482d-9564-5867df1c936f6
1000114medroxyprogesterone acetate 10 MG Oral TabletSCDcbf142f9-9af3-4d79-9343-0ab42d6dbe9f6
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN419479ee-c1e1-306c-e054-00144ff8d46c5
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN0df6fd1e-7d9c-4a38-848c-1e562e211c915
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD419479ee-c1e1-306c-e054-00144ff8d46c5
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD0df6fd1e-7d9c-4a38-848c-1e562e211c915
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN826f674c-8ef2-400a-bf0b-877320a8cb5d3
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN0de6142f-a78e-ae58-e063-6394a90adff03
1000141medroxyPROGESTERone acetate 5 MG Oral TabletPSN826f674c-8ef2-400a-bf0b-877320a8cb5d3
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD0de6142f-a78e-ae58-e063-6394a90adff03
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD826f674c-8ef2-400a-bf0b-877320a8cb5d3
1000141medroxyprogesterone acetate 5 MG Oral TabletSCD826f674c-8ef2-400a-bf0b-877320a8cb5d3
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSNe5f5c46c-b8b7-4502-9d2b-8f12284d1a632
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN1403a9a9-c04a-432f-8819-4850f779312e2
1000114medroxyprogesterone acetate 10 MG Oral TabletSCDe5f5c46c-b8b7-4502-9d2b-8f12284d1a632
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD1403a9a9-c04a-432f-8819-4850f779312e2
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSNab82d81a-fb06-ff34-e053-2a95a90a12ef1
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSNfda3368b-4ce3-4972-885d-066858831ee01
1000135medroxyPROGESTERone acetate 2.5 MG Oral TabletPSNfda3368b-4ce3-4972-885d-066858831ee01
1000141medroxyPROGESTERone acetate 5 MG Oral TabletPSNfda3368b-4ce3-4972-885d-066858831ee01
1000114medroxyprogesterone acetate 10 MG Oral TabletSCDab82d81a-fb06-ff34-e053-2a95a90a12ef1
1000114medroxyprogesterone acetate 10 MG Oral TabletSCDfda3368b-4ce3-4972-885d-066858831ee01
1000135medroxyprogesterone acetate 2.5 MG Oral TabletSCDfda3368b-4ce3-4972-885d-066858831ee01
1000141medroxyprogesterone acetate 5 MG Oral TabletSCDfda3368b-4ce3-4972-885d-066858831ee01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-0779-0200555077902100 TABLET in 1 BOTTLE (0555-0779-02) 100 tablet1996-12-040000-00-00NoNoCurrent
0555-0779-0400555077904500 TABLET in 1 BOTTLE (0555-0779-04) 500 tablet1996-12-040000-00-00NoNoCurrent