Metronidazole

Product NDC: 29300-227
11-digit product format: 293000227
Labeler code: 29300
Product ID: 29300-227_afe0fa12-6438-4bd6-9a71-1f248bc9c54d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metronidazole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA203458
Marketing category: ANDA
Marketing start: 2014-06-01
Substance: METRONIDAZOLE
Active strength: 500 mg/1
Pharmacologic classes: Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203458-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2014-01-22
A203458-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2014-01-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203458-001	AB
A203458-002	AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203458-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2014-01-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203458-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2014-01-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203458-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203458-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203458-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203458-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203458-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203458-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203458-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203458-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203458-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203458-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203458-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203458-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203458-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203458-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203458-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203458-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203458-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203458-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203458-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203458-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203458-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203458-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203458-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203458-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203458-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203458-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203458-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203458-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203458-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203458-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203458-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203458-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203458-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203458-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203458-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203458-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203458-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203458-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203458-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Metronidazole
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METRONIDAZOLE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
140QMO216E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311681	Internal RxNorm lookup
314106	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
9219588b-0a99-40b9-bdd4-ced6d6efebed	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55	Product name	5	20251024
7f6d14e0-4366-41bc-a4a9-b74c79a20e17	Product name	1	20250623
e6d321b0-0e5e-7da6-f043-92b6a91f00a1	Product name	5	20250515
e1aac33b-94ae-4ee9-905b-299f7263853b	Product name	3	20250124
16642716-d28a-4f90-8dcb-3921cd8c8109	Product name	4	20240516
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15	Product name	1	20240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
a5070875-62bb-61e1-fd46-8f7054197a40	Product name	8	20180215
0add4de9-d152-3375-3390-1123dddc5e3d	Product name	1	20140508
33ca0fcc-1011-92dc-50a9-a383683eed1e	Product name	1	20140508
53f39d9f-cd3f-04e1-c668-d4580719d57d	Product name	1	20140508
a804000f-b74f-0b5d-d17b-aa767c286ddb	Product name	1	20140508
a91ea265-6e02-c08f-93c8-686d54180529	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
29300-227-01	Metronidazole	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	16
29300-227-05	Metronidazole	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	16
29300-227-10	Metronidazole	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000	16
29300-227-46	Metronidazole	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-227-01	EA - Each	29300-227	160cf9d9-97d8-4ad5-a4de-879e29b13ee3	1	2014-09-03
29300-227-05	EA - Each	29300-227	b7e75f34-70c0-49de-b782-14be6109ac88	1	2014-09-03
29300-227-46	EA - Each	29300-227	41bf7bbe-bf53-4660-98dc-56a3c9acf9e6	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	3
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [DIRECT RX]	2
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [DIRECT RX]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	METRONIDAZOLE TABLET [DIRECT RX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE TABLET [DIRECT RX]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	METRONIDAZOLE TABLET [DIRECT RX]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE TABLET [DIRECT RX]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METRONIDAZOLE TABLET [DIRECT RX]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	METRONIDAZOLE TABLET [DIRECT RX]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-227	METRONIDAZOLE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]	16	Current NDC, Legacy NDC, 4 package rows	20240806_9219588b-0a99-40b9-bdd4-ced6d6efebed.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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	2f7d84d4-1085-4243-be88-442eecb85205	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	cfeab9e3-58b9-4890-9185-11b62904e2af	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	cbee69e8-029c-49d2-89cd-f504b8e0ac28	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	3e0a14f1-961b-4722-bfea-aafcc5d7706c	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	49bed450-7fa8-401c-8c8c-afc1c61d473a	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	3c0ebb00-a0ae-4f64-9bfc-de01193191e8	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Coupler LLC	545f2900-745c-c33c-e063-6294a90a5e4f	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Coupler LLC	509c8d03-e199-8154-e063-6394a90afddc	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	St. Mary's Medical Park Pharmacy	60689b96-cb58-925a-e053-2a91aa0a32a3	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	1277591d-ccf4-428a-b647-cb1ef3fbf561	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	02046a22-a5eb-4bb7-bec7-e5a2aa55e142	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	BluePoint Laboratories	3cf021b6-5794-4a86-b09d-bece0ba8b302	2026-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
METRONIDAZOLE	METRONIDAZOLE	Direct_Rx	90a5acb3-f8cc-1e82-e053-2995a90a4e97	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Proficient Rx LP	a56c2842-8ad4-4396-8eb6-cbcd1629fcb1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals, Inc.	4040db14-750f-6d20-e054-00144ff8d46c	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	Redpharm Drug	32523df9-8c47-200f-e063-6294a90ac890	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	60ad086d-6f54-4134-b608-53a6ff571ff8	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	2a5af710-dbf7-41c1-9b3a-35e69b3fa4ab	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	9a18debb-3bb8-4b23-949b-aaa0f3b62191	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458
Metronidazole	METRONIDAZOLE	PD-Rx Pharmaceuticals, Inc.	353b7f5b-4bbc-4ec9-84ba-d82656ea1811	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203458 application number: ANDA203458

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
140QMO216E	METRONIDAZOLE	443-48-1	METRONIDAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	1277591d-ccf4-428a-b647-cb1ef3fbf561	100
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	daee5e69-aa86-470b-81b7-3074d27fc847	100
311681	metronidazole 500 MG Oral Tablet	SCD	daee5e69-aa86-470b-81b7-3074d27fc847	100
311681	metronidazole 500 MG Oral Tablet	SCD	1277591d-ccf4-428a-b647-cb1ef3fbf561	100
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	3c0ebb00-a0ae-4f64-9bfc-de01193191e8	32
311681	metronidazole 500 MG Oral Tablet	SCD	3c0ebb00-a0ae-4f64-9bfc-de01193191e8	32
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	49bed450-7fa8-401c-8c8c-afc1c61d473a	29
311681	metronidazole 500 MG Oral Tablet	SCD	49bed450-7fa8-401c-8c8c-afc1c61d473a	29
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	9a18debb-3bb8-4b23-949b-aaa0f3b62191	26
311681	metronidazole 500 MG Oral Tablet	SCD	9a18debb-3bb8-4b23-949b-aaa0f3b62191	26
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	60ad086d-6f54-4134-b608-53a6ff571ff8	21
311681	metronidazole 500 MG Oral Tablet	SCD	60ad086d-6f54-4134-b608-53a6ff571ff8	21
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	2a5af710-dbf7-41c1-9b3a-35e69b3fa4ab	18
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	4cdd7ac5-a52c-4766-afeb-1b5e567a328c	18
311681	metronidazole 500 MG Oral Tablet	SCD	2a5af710-dbf7-41c1-9b3a-35e69b3fa4ab	18
311681	metronidazole 500 MG Oral Tablet	SCD	4cdd7ac5-a52c-4766-afeb-1b5e567a328c	18
314106	metroNIDAZOLE 250 MG Oral Tablet	PSN	9219588b-0a99-40b9-bdd4-ced6d6efebed	16
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	9219588b-0a99-40b9-bdd4-ced6d6efebed	16
314106	metronidazole 250 MG Oral Tablet	SCD	9219588b-0a99-40b9-bdd4-ced6d6efebed	16
311681	metronidazole 500 MG Oral Tablet	SCD	9219588b-0a99-40b9-bdd4-ced6d6efebed	16
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	2f7d84d4-1085-4243-be88-442eecb85205	12
311681	metronidazole 500 MG Oral Tablet	SCD	2f7d84d4-1085-4243-be88-442eecb85205	12
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	48836437-c2c2-1ea2-e054-00144ff8d46c	10
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	cdd942a1-fb3b-4912-bd3f-8aef451e6a3c	10
311681	metronidazole 500 MG Oral Tablet	SCD	48836437-c2c2-1ea2-e054-00144ff8d46c	10
311681	metronidazole 500 MG Oral Tablet	SCD	cdd942a1-fb3b-4912-bd3f-8aef451e6a3c	10
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	4040db14-750f-6d20-e054-00144ff8d46c	8
311681	metronidazole 500 MG Oral Tablet	SCD	4040db14-750f-6d20-e054-00144ff8d46c	8
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	6e5ea18b-7ccc-08fc-e053-2991aa0a7944	7
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	60689b96-cb58-925a-e053-2a91aa0a32a3	7
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	0d8125d6-173f-4498-85a9-a1323c7a0e42	7
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	a56c2842-8ad4-4396-8eb6-cbcd1629fcb1	7
311681	metronidazole 500 MG Oral Tablet	SCD	a56c2842-8ad4-4396-8eb6-cbcd1629fcb1	7
311681	metronidazole 500 MG Oral Tablet	SCD	60689b96-cb58-925a-e053-2a91aa0a32a3	7
311681	metronidazole 500 MG Oral Tablet	SCD	0d8125d6-173f-4498-85a9-a1323c7a0e42	7
311681	metronidazole 500 MG Oral Tablet	SCD	6e5ea18b-7ccc-08fc-e053-2991aa0a7944	7
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	fb306ef2-5203-4034-b699-b8657c7ef257	6
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	90a5acb3-f8cc-1e82-e053-2995a90a4e97	6
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	1abb2827-67e4-43c0-9762-8261f480fc3a	6
311681	metronidazole 500 MG Oral Tablet	SCD	90a5acb3-f8cc-1e82-e053-2995a90a4e97	6
311681	metronidazole 500 MG Oral Tablet	SCD	fb306ef2-5203-4034-b699-b8657c7ef257	6
311681	metronidazole 500 MG Oral Tablet	SCD	1abb2827-67e4-43c0-9762-8261f480fc3a	6
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	b8fd8441-624d-4600-b1ca-17d5be73b203	5
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	4fbe2b3f-4c6f-43b7-e054-00144ff8d46c	5
311681	metronidazole 500 MG Oral Tablet	SCD	4fbe2b3f-4c6f-43b7-e054-00144ff8d46c	5
311681	metronidazole 500 MG Oral Tablet	SCD	b8fd8441-624d-4600-b1ca-17d5be73b203	5
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	b1d13c9f-cf8e-4646-e053-2a95a90a4a35	4
311681	metronidazole 500 MG Oral Tablet	SCD	b1d13c9f-cf8e-4646-e053-2a95a90a4a35	4
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	90a6139b-66e8-7754-e053-2a95a90af815	3
311681	metronidazole 500 MG Oral Tablet	SCD	90a6139b-66e8-7754-e053-2a95a90af815	3
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	be23affb-5b30-40ee-b0b5-829666bafaeb	2
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	cbee69e8-029c-49d2-89cd-f504b8e0ac28	2
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	8b0f1827-57cd-ed40-e053-2995a90a0630	2
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	932677ef-0123-4481-ba11-8bd8065c653b	2
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	90a56d96-a454-3fb3-e053-2a95a90ad291	2
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	2783e34b-384d-04af-e054-00144ff8d46c	2
311681	metronidazole 500 MG Oral Tablet	SCD	932677ef-0123-4481-ba11-8bd8065c653b	2
311681	metronidazole 500 MG Oral Tablet	SCD	be23affb-5b30-40ee-b0b5-829666bafaeb	2
311681	metronidazole 500 MG Oral Tablet	SCD	90a56d96-a454-3fb3-e053-2a95a90ad291	2
311681	metronidazole 500 MG Oral Tablet	SCD	8b0f1827-57cd-ed40-e053-2995a90a0630	2
311681	metronidazole 500 MG Oral Tablet	SCD	cbee69e8-029c-49d2-89cd-f504b8e0ac28	2
311681	metronidazole 500 MG Oral Tablet	SCD	2783e34b-384d-04af-e054-00144ff8d46c	2
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	9adc9cc1-08a1-62b9-e053-2a95a90aee4a	1
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	509c8d03-e199-8154-e063-6394a90afddc	1
311681	metroNIDAZOLE 500 MG Oral Tablet	PSN	08fcd3b0-473a-433d-ae09-0c8a47441fee	1
311681	metronidazole 500 MG Oral Tablet	SCD	9adc9cc1-08a1-62b9-e053-2a95a90aee4a	1
311681	metronidazole 500 MG Oral Tablet	SCD	08fcd3b0-473a-433d-ae09-0c8a47441fee	1
311681	metronidazole 500 MG Oral Tablet	SCD	509c8d03-e199-8154-e063-6394a90afddc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-227-01	29300022701	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-227-01)	2014-06-01	0000-00-00	No	No	Current
29300-227-05	29300022705	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-227-05)	2014-06-01	0000-00-00	No	No	Current
29300-227-10	29300022710	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-227-10)	2014-06-01	0000-00-00	No	No	Current
29300-227-46	29300022746	50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-227-46)	2014-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metronidazole Tablets USP	REMEDYREPACK INC.	2026-07-22	HUMAN PRESCRIPTION DRUG LABEL	13
Metronidazole Tablets USP	Preferred Pharmaceuticals Inc.	2026-07-07	HUMAN PRESCRIPTION DRUG LABEL	3
Metronidazole Tablets USP	REMEDYREPACK INC.	2026-06-23	HUMAN PRESCRIPTION DRUG LABEL	33
Metronidazole Tablets USP	REMEDYREPACK INC.	2026-06-23	HUMAN PRESCRIPTION DRUG LABEL	30
Metronidazole Tablets USP	Coupler LLC	2026-04-29	HUMAN PRESCRIPTION DRUG LABEL	1
Metronidazole Tablets USP	St. Mary's Medical Park Pharmacy	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	7
Metronidazole Tablets USP	Bryant Ranch Prepack	2026-04-13	HUMAN PRESCRIPTION DRUG LABEL	100
METRONIDAZOLE 500mg	Direct_Rx	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	6
Metronidazole Tablets USP	Proficient Rx LP	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	7
Metronidazole Tablets USP	NuCare Pharmaceuticals, Inc.	2025-12-19	HUMAN PRESCRIPTION DRUG LABEL	8
Metronidazole Tablets USP	A-S Medication Solutions	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	26
Metronidazole Tablets USP	A-S Medication Solutions	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	21
Metronidazole Tablets USP	A-S Medication Solutions	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	18
Metronidazole Tablets USP	PD-Rx Pharmaceuticals, Inc.	2025-10-02	HUMAN PRESCRIPTION DRUG LABEL	18
Metronidazole Tablets USP	Bryant Ranch Prepack	2025-09-26	HUMAN PRESCRIPTION DRUG LABEL	6
Metronidazole Tablets USP	NuCare Pharmaceuticals,Inc.	2025-05-28	HUMAN PRESCRIPTION DRUG LABEL	4
Metronidazole Tablets USP	Quality Care Products LLC	2024-12-17	HUMAN PRESCRIPTION DRUG LABEL	7
Metronidazole Tablets USP	Bryant Ranch Prepack	2024-10-08	HUMAN PRESCRIPTION DRUG LABEL	100
Metronidazole Tablets USP	PD-Rx Pharmaceuticals, Inc.	2024-08-19	HUMAN PRESCRIPTION DRUG LABEL	25
Metronidazole Tablets USP	Bryant Ranch Prepack	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	10
Metronidazole Tablets USP	Unichem Pharmaceuticals (USA), Inc.	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	16